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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
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Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
Comprehensive Regulatory affairs for new product and market authorizations, Health Authority submissions, post-approvals, CMC and lifecycle management... Know More
Streamlining entire publishing and submission management process right from planning, dossier development, tracking, publishing, submissions and delivery confirmation... Know More
End-to-end labeling services and software support for global and regional labeling management, CCDS creation and updation, core to local label alignment etc... Know More
Freyr is a leading provider of artwork services & solutions for global life sciences industry - Pharmaceuticals, Medical Devices, Cosmetics, and Consumer Healthcare... Know More
Specialized GxP audit, QMS Remediation, Process and Product Validation and GxP Solution consulting services to assist Life Sciences organizations comply with Health Authority requirements... Know More
Enabling Life Sciences organizations reach global markets with impeccable product, market and Regulatory pathway strategies, Regulatory intelligence, and enterprise process consulting... Know More
Keeping abreast of the ever-changing Regulatory environment, Freyr enables Lifesciences organizations take informed decisions to create superior market strategies... Know More
World-class Regulatory and medical writing services to put across scientific and clinical information in a clear, concise and compliant way... Know More
Freyr ARTWORK 360 intelligently solves the challenges of managing and delivering artwork at every stage of its development. As a single-stop solution, it provides electronic review, approval, publishing, and storing all artwork documents. By focusing on collaboration, from gathering information to delivering transparent workflows and processes, Freyr ARTWORK 360 simplifies production and gives greater visibility to all stakeholders in the organization.
Freyr SUBMIT PRO is a complete, smart eCTD software product for the creation, validation, publishing, viewing and reporting of Regulatory documentation for electronic submissions by pharmaceutical companies to Regulatory authorities.
Freyr rDMS is an end-to-end electronic Regulatory Document Management solution exclusively designed to enable Regulatory Groups and Departments within a life sciences organization to seamlessly create, capture, manage, organize, connect, deliver and archive Regulatory data and documents in a compliant, efficient and intuitive manner.
Freyr iREADY is a customized solution to meet all the Cosmetic ingredients information requirements. Freyr iREADY ensures overcoming information challenges with a centralized repository for ingredients, single-source of global Regulatory information, and real-time intelligence and integration.
Freyr IMPACT is an innovative Regulatory Intelligence Enterprise Platform solution offering a complete spectrum of Regulatory intelligence services across comprehensive product and regulation categories to provide detailed and customized insights. Freyr IMPACT gathers and analyzes publicly available Regulatory information. This includes communicating the worldwide reach of regulations, life sciences industry updates using a system, and monitoring the current regulations, guidance, policy, and legislation.
Freyr LABEL 360 is one such comprehensive label life cycle management tool through which companies can manage the label changes globally in a streamlined and timely manner. The overarching principle of Freyr LABEL 360 is to integrate industry best practices by bridging the gaps within the global and regional labeling processes and to control the flow of labeling information from core label change to regional label implementation through artwork, supply chain and printing phases.
Structured Product Labeling (SPL) & Structure Product Monogram (SPM) is the mandatory document markup standard for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format. SPL/SPM format defines the structure and content of label information as required by the United States Food and Drug Administration (US FDA) and Health Canada. The US FDA has mandated SPL requirements for over 50 types of documents, and HC has mandated SPM requirements for over 6 types of documents.
Freyr IDENTITY leverages the Plan, Process and Training methodology to offer an end-to-end UDI compliance solution. Suitable for a company of any size with any number of devices, Freyr IDENTITY is exclusively designed to streamline the complete compliance process by connecting disparate internal functions and integrating data sources and formatted information with a centralized database for automated XML generation and submission that meets all the FDA regulated UDI mandates.
Multiple products, multiple markets, combined with varied Regulatory requirements challenge Life Sciences organizations to capture and maintain wide variety of information in order to obtain Health Authority (HA) approvals.
Radically redefining the global Regulatory solutions and services landscape for Bio-Pharma (Innovators / Generics), Consumer Healthcare and Medical Device companies.
Dear Freyr team, I wanted to tell you how lucky/grateful/appreciative/thankful we are to have a support team like you to assist our last-minute submissions for new drug approval. This is a continuum of support from the team, but the recent one was another demonstration of excellence. Thank you!
– Executive Director, Regulatory Affairs Ireland-based, Global Specialty Pharmaceutical Company
Thank you, Freyr. Our team had a good experience with your team, both in the past and now. We will require your services again in the near future.
– Sr. Vice President - Regulatory Affairs India-based, Leading Multi-faceted Pharmaceutical Company
I am impressed by the team Freyr. I have worked with other vendors that provided publishing support, but what sets Freyr apart is that they act more like team members, adding expertise to changes in guidance and advice on navigating rather than just taking a publishing task and providing an output. In my experience, other vendors needed detailed instructions. But Freyr better understands what is needed by partnering with RA and fostering open lines of communication.
– Associate Director, Regulatory Operations Japan-based Global Innovative Pharmaceutical Company
“I’ll add my personal thanks and appreciation for all the good work and the extra efforts you have put in to support the NDA submissions. I really appreciate your expertise and accountability. Thank you for a job well done.
– CEO & President US-based, Leading Innovator Pharmaceuticals Manufacturing Company
Thank you, Freyr, for your extraordinary efforts to support the mandatory NDA submissions. Submitting more than 20,000 files associated with the cardiac safety study required as a post-approval commitment was an unplanned activity. And the magnitude of the effort needed to receive so many files, process them to the appropriate format, and publish them for e-submission through the FDA gateway was a real surprise to all! We could not have accomplished this without your support and commitment after hours to get the work done correctly. You are a valuable and much-appreciated addition to our team.
Thank you, and well done!
– Senior Vice President, Regulatory Affairs US-based, Leading Innovator Pharmaceuticals Manufacturing Company
As always, thank you so much for your help with this submission! The efforts are very much appreciated!
– Sr. Regulatory Affairs Specialist US-based, Multinational Pharmaceuticals CRO Company
We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, flexibility, and sense of urgency and priority are deeply appreciated.
Please keep up the great work, as we have many milestones to achieve over the next year.
– Global CMC Technical Lead A China-based Pharmaceutical Company
I just wanted to send you a quick note to let you know that Freyr’s resources have really stepped up this week. They are working on a submission that is taking an incredibly long time to prepare. They worked late last night and continue to plug away at it this morning. They have kept a positive attitude and have displayed true professionalism. I appreciate all that the publishers do for us, but I wanted to let you know how they have gone above and beyond this week.
– Director, Regulatory Affairs Operations A US-based, Pharmaceutical Company
I just wanted to say how pleased we are with Freyr and one of their team member’s work. They have quickly come up to speed and doing a great job. Thank you for listening to our needs and finding such a great match.
– Senior Director, Specialty Regulatory Affairs US-based, Global, Pharma Company
I would really like to take this time to give well-deserved recognition to the Freyr team. From last-minute changes with report-level publishing to everyday submissions, the Freyr team really managed everything efficiently. They worked very late in publishing high-priority submissions flawlessly.
Freyr team’s publishing skills are top-notch, and they quickly adapt to every situation they face. I cannot commend their flexibility enough.
Thank you, Freyr, for providing such great people to support us. The team is really dedicated, and it’s palpable. They are professional, knowledgeable, and made the transition smoother.
We are looking forward to working with the team more in the future.
– Sr. Regulatory Submission Publishing Lead UK based, Global Specialty Pharmaceutical Company
Thank you, Freyr team, for all your hard work and excellent support for this IND. I especially want to highlight your work over this past weekend and address the comments by Monday morning. Overall, module 3 looked really, really amazing, with all the links and bookmarks in place, which I know took a great deal of work, and it was done in a very short period of time. Bravo!
– Manager, Global Regulatory Affairs, CMC Japan-based, Global Specialty Pharmaceutical Company
We want to thank the entire Freyr’s Team for presentation, explanation, and dedication. We very much appreciate having a partner in addressing our questions, inquiries, and most of all, getting back answers. Thank you so very much!”
– Quality Manager A Romanian Food Manufacturing Company
Thank you very much for the report. It is very clear and helpful. I have received the information I was looking for and am now able to address our challenges!”
– Regulatory Affairs Specialist A Denmark-based Food Ingredient Manufacturing Company
The report is very clear and detailed with many valuable insights, which are of high quality. Very friendly and fast communication and support. Clear roles and responsibilities in the project, presented in a good way.”
Freyr’s services are very good. We will move with other projects too.
– Pharmaceutics Lead – R&D A Singapore-based Wellness & Fitness Company
We would like to thank Freyr for their work on label suitability in the US market. Freyr’s expertise, punctuality, flexibility, enthusiasm, and prompt responses were all appreciated during the project. We are very satisfied with our collaboration, and we hope we can work together in the future again!”
– Business Development & Alliance Lead A Switzerland-based Nutritional Products Manufacturing Company
Freyr is working perfectly in every area. We have nothing to complain about.
– Regulatory Affairs Consultant
Documentation was very satisfactory. I thank Freyr for the participation throughout the NDIN process.”
–Global RA Deputy Manager A South-Korean Pharmaceutical Company
Brilliant, as always. I appreciate the work you have done.
– Global Director of Regulatory Affairs A US-based Dietary Supplements Manufacturing Company
Thank you very much for a nice closure! It has been a pleasure working with you all. I want to take this opportunity to thank you for all your support with our newsletter's projects during the past 2.5 years, the excellent collaboration, and communication. The dedication and professionalism of your team were greatly appreciated. All the projects were delivered on time and were compliant with our quality standards.
The team followed attentively and patiently addressed all the changes in our IT systems and processes and acted as a true partner providing valuable comments to draw attention to some points or issues about the content. I enjoyed working with the team and hope we will have new opportunities to continue our collaboration in the future.
THANK YOU and Season's Greetings!!
– Regulatory Consulting Manager A global leader in providing trusted insights and analytics
All people involved in this project were very helpful, knowledgeable and fast. Freyr performed more than we expected. Outstanding service!
– A Swiss-based Nutraceuticals Company
Thank you Freyr. This is excellent and will be super helpful.
– Global Director, Regulatory Affairs A Utah-based multi-level marketing company
Thank you so much for sending the assessment reports. The reports are presented in a structured and clear way. We highly appreciate your support.
– Leiter Regulatory Affairs / Head of Regulatory Affairs A Cosmetic Manufacturer
I am sure you have heard by now that we have received the first ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team. I would be remiss if I did not point out that we would not have been able to do this without the help of Freyr’s dedicated team. From the original filing, then the following year of responses, Freyr’s team has helped us to get to final approval.
Thank you Freyr team for a job well done!
– Sr. Director, Head of Regulatory Operations and Strategic Business Solutions A Global Specialty Pharmaceutical Company
Freyr has been doing exemplary work in the QC Monitoring space for one of our workstreams. Continue the good work.
– Associate Director Labeling Digital Enablement One of the World’s Largest Pharmaceutical Companies
It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.
– President An Innovative Pharmaceutical Company
Freyr has done the excellent job on the IND reactivation. Specifically, the high-quality module 3 written by the team; it was very comprehensive, and we had no questions from Health Canada or the FDA. No CMC questions, that was a first for us. Also, thanks for being very responsive to many requests which I am sure can be frustrating, but always helpful while producing excellent work. Thank you for always being available and responding quickly and comprehensively to all the requests with the most positive attitude. What a great team you have Freyr!
– RA Consultant US based, Leading Pharmaceuticals manufacturing Company
Thanks a lot for your extended support in the last moment. We really appreciate your amazing dedication and efforts.
– Regulatory Affairs (Formulation R&D) A Global Player in API Manufacturing
Kudos to you all for the brilliant teamwork!! Alone, we can do so little; together, we can do so much. Looking forward to the next milestone and collaboration on new projects in future.
– SVP - R&D (Finished Dosage Form) A Global Player in API Manufacturing
Many thanks for your efforts, especially at the last minute.
– A Technology-driven Contract Research Organization (CRO)
We’ve done it! Answers successfully transferred to MoH. Thank you very much for all the support last week and your incredible passion to cope with this.
– Regulatory Affairs Specialist A Global Biopharmaceutical Company
I believe that a very high level of trust has been earned among us. Freyr’s team understood our needs and responded quickly. Freyr gave us many good and professional suggestions, which helped us make right decisions. To be honest, the overall value is relatively high. They ensured the submission was on time and acted as a responsible cooperative partner all through. Overall, on a scale of 1 to 100, we can give Freyr 100. We are looking forward to our next cooperation with Freyr.
We are very excited to start working with Freyr team on the first SOW deliverables. It’s already a positive feedback from our project lead on the progress and working relationship thus far. Basis the same, we would like to work with Freyr on an additional project different than the current SOW. The second project would be in relation to the development of a technical operations manual for a Software based digital solution (Software as a Medical Device).
– Head, Global Labeling Radiology Devices A Global Enterprise with Core Competencies in Life Sciences Fields of Health Care and Agriculture
Many thanks to Freyr team for the assistance in the critical submission of the SFDA. It was challenging all through the process, a tough one – but for sure made all of us prepared for next projects
– Regulatory Affairs Associate A Global Pharmaceutical Company
It is our pleasure to work with Freyr. They are responsive and addressed all our queries and met given deadlines to meet our demands. Freyr has definitely been a great help. We hope that we can maintain this relationship in the future too.
– Product Compliance Specialist Singapore based, Cosmetics Company
Freyr’s support was unbelievably helpful and quite comprehensive.
– VP of Compliance US based, Leading Consumer Products Company
Thank you for your ongoing support with the RFA review process! We’ve moved a fair few forward recently, which is great to see! Given this, I was just wanting to enquire as to if you can take on 5 more Shower Gel RFAs that we have coming through for 1st review?
– Global Regulatory Affairs Associate A British Multinational Consumer Goods Company
Indeed, we were satisfied with Freyr’s services. The whole interaction, content, additional info (Q&A), timelines and communication were really good. We wish you all the best in the New Year 2021 and we hope to stay closely connected for more reports and collaboration.
-Director - Regulatory Affairs A Croatia-based Pharmaceutical Company
Many thanks for the support to pull this RFA through. We appreciate your efforts in gap analysis.
- Head of Regulatory Affairs A British Multinational Consumer Goods Company
I know how you spent great effort to complete the notification. Thank you very much and we really appreciate your kind help for the solution/result-oriented work. Thanks again.
-International Regulatory Affairs Specialist A Market Leader in Infection Prevention Solutions
The reports were very detailed, and generally either confirmed some of our assumptions or provided some new context around claims or administrative practices that helped complement our understanding. Thank you so much for the diligence towards the reports.
-Global Regulatory Director US-based Leading Clinical-Stage Biotechnology Company
Thank you Freyr for your professionalism, help and all-time support. We appreciate the work of Freyr team and look forward to start other projects soon.”
- International Sales Department A Leading Clinical-Stage Biotechnology
We prepared an urgent submission that had many pieces and documents arriving throughout the day, and we did not receive our final piece of content until late night. It was essential that the submission be sent on the same day. Freyr’s resources were critical in making the submission happen and meeting the deadline. They went above and beyond to support us and I’m lucky and thankful to have them as a part of my team.
- Director – Regulatory Operations US-based Leading Clinical-Stage Biotechnology Company
We love working with Freyr and have been very impressed with their team. We plan on introducing our own branded products (or other white label products) in Indonesia with them in the future.
- Partner A Professional Corporation
Performance is way beyond our expectations, even before to the project initiation. Thanks for your kind support again.
- President A Healthcare Activation Leader in Providing Strategic Solution for The Rx/ OTC, Health Supplement, Processing Foods, Cosmetics and Medical Networking Business
Freyr’s approach was kind and careful in this project and here I would like to give my best regards to the entire team of Freyr. Thanks again for the cooperation and we could expect another chance in the future.
Thank you so much Freyr for all the hard work and dedication you guys have shown to this submission. We appreciate your dedication to this project, especially to work on a national holiday. On behalf of all the RA members involved, please accept our gratitude. Thank you again.
- Sr. Regulatory Operations Specialist A Japanese Pharma Group
I would like take this opportunity to express our sincere appreciation for Freyr team. They did a wonderful job supporting a submission over the thanksgiving holidays. They are very collaborative and ready to take on tasks even in the last minute. They are always willing to learn and look for more opportunities to expand their knowledge. Really appreciate their continuous support and help.
- Sr. Manager, Regulatory Operations> An American-Irish Manufacturer of Specialty Pharmaceuticals, Generics Drugs
The entire Freyr team was exceptionally responsive and collaborative in providing a quick turn-around and a quality product, which allowed us to meet a critical FDA deadline. We are extremely thankful for the extra effort put forth by the Freyr team in the preparation of this submission. We look forward to working with Freyr again soon.
- Associate Director, Regulatory Affairs Australia Based Leading Regenerative Medicine Company
Freyr is the best! Thank you, for relentless support, effort and curiosity for our projects! Kudos to all in the Freyr team!!!
- Quality Assurance Manager A U.S. based Generic Pharmaceutical Company
Thank you Freyr team for supporting and making the ANDA submission happen without any deficiencies. We would also like to extend our thank you to the Freyr publishing team. Let’s continue this!
- Senior Associate – Regulatory Affairs A US based Generic Pharma Company
I would like to thank everyone in Freyr for their support with the QMS enhancements. We are closer to increasing our goals of inspection readiness. Their continued follow-ups are greatly been appreciated. We feel very positive about the progress. Special thanks for facilitating\leading an EXCELLENT and smooth demo. Awesome job!!! I know we have a few more boxes to check before Go Live, but everyone THANK YOU!!! I know it’s a TEAM effort, it shows! The system is looking really nice. A sheer example of Excellence!
- Sr. Director, Global Regulatory Affairs-Operations (GRO) India based, Global Top Generic Pharma Company
Thank you for your meticulous work and support through many projects while some of them very challenging, and for your valuable contributions in achieving our goals!
- Senior Medical Director, A leading Research-based Biopharmaceutical Company
Thank you to the entire Freyr team for pulling out all the stops to push the PPM Master through in just one-day for the launch. We appreciate everyone’s time and efforts to meet this extremely short timeline.
- Global Regulatory Affairs Canada Based Leading Pharmaceuticals Company
I am not sure if Thank You is good enough to do justice to what Freyr’s team has done. I truly appreciate the partnership, dedication and the commitment of the Freyr team.
- Senior Vice President, Global Regulatory Affairs Canada Based Leading Pharmaceuticals Company
Excellent. As always, thank you and the Freyr team for your timely efforts! Have a great holiday weekend
- Director, Regulatory Affairs A Speciality Pharmaceutical Company
Thank you Freyr team for your support on the BLA submission. I appreciate Freyr’s support on the compilation, publishing and QC of the documents as well as the ongoing tracking of the issue log data. Appreciate Freyr team for relentless support on the weekends for this submission which helped us to meet our company goal.
- Senior Manager, Regulatory Operations A Leading Global Specialty Pharmaceuticals Company
Thank you Freyr team. We were able to sign-off internally on all the artwork files Freyr helped us with. I appreciate Freyr’s professionalism, and quick turnaround. Project met its stated objectives. Thanks!
- CEO A US Based Pharmaceutical Company
Thank you Freyr for your hard work and support of the submission with a quick turnaround. We really appreciate Freyr’s expertise and are very pleased to be working with Freyr team.
- Vice President, Regulatory Affairs CMC US Based Leading Clinical-Stage Biotechnology Company
The news of our product approvals is wonderful! Thank you so much for all that the Freyr team has done and continue to do for us; we really appreciate it.
- Regulatory Affairs Specialist US Based Leading Skincare Products Manufacturer
Thank you very much Freyr team for the kind help and support. The service Freyr provided us with and their assistance were brilliant!
- Sales Manager Manufacturer of High-Quality Oral Brands
Thank you so much Freyr for being a great partner in our Regulatory compliance journey. As safety assessment is a key requirement in ASEAN countries, Freyr’s support has helped us significantly in meeting those requirements well ahead in Vietnam.
- R&D Manager A Leading Beauty and Wellness Products Company
Thank you. This entire pandemic experience is very strong validation of our model/ mission. Our collaboration with the Freyr team has helped us support the US health systems and the patients they serve in this time of crisis and beyond.
- Chief Quality & Regulatory Affairs Officer A leading generic drug and pharmaceuticals company
Wow – thank you Freyr. Amazing job and team effort.
- Project Manager, New Product Launch Canada Based Global Pharmaceutical Company
Excellent turnaround to pave the way for artwork launch on time. Excellent Collaboration with Freyr.
- Director, New Product Launch Canada Based Global Pharmaceutical Company
Great team collaboration by Freyr. Perseverance has no boundaries at Freyr, no matter whether they work onsite or from home!”
- Director, Global Regulatory Affairs (Labeling) Canada Based Global Pharmaceutical Company
Thank you to all the folks in Freyr team for pulling off this artwork launch in just one day.
- SVP, Global Regulatory Affairs Canada Based Global Pharmaceutical Company
Freyr’s diligence, thorough input, and timely delivery of all requests have been noted and are greatly appreciated.
- Regulatory Manager Global Top 5, Pharma & Consumer Healthcare Company
I have to say that up to now I am very happy with the cooperation level and responsiveness of Freyr Team!
- Regulatory Affairs Manager A British-Dutch Transnational Consumer Goods Company
Thank you Freyr! This is a very detailed review thank you.
- Senior Manager, Global Regulatory Health Strategy & Operations A British Multinational Consumer Goods Company
Congratulations to the entire Freyr Global Solutions team! It has been a complex exercise for both of us, and I am so glad to achieve a successful end.
- Group Leader An American Multinational Confectionery, Food, Holding and Beverage Company
SPAR has streamlined our processes, brought together our scattered data pieces and improved our data quality., ultimately helping us to better manage RI. SPAR intervention made lifecycle management easy by sending out automated notifications. Notifications drastically improved our operational efficiency. Appreciate Freyr team’s devotion. Kudos to their technology and the teams that worked behind this.
- VP, Regulatory Affairs A leading India-based healthcare organization
I would like to thank Freyr for their fantastic performance. Their knowledge and attitude towards work is of top class, and their commitment towards work and technical expertise is outstanding. This has helped us deliver the POC and I am sure we will soon deliver the production environment as well. I would like to appreciate Freyr’s sense of ownership and willingness to resolve issues that were sometimes beyond the expected line of duty.
- Management Consultant An Indian Multinational Corporation Specialized in Business Consulting
Please let us take this opportunity to thank the entire Freyr team for their kind support. We are using Freyr SUBMIT PRO with an increasing confidence and getting used to the advantages of the technology. We would appreciate Freyr’s continuous support for this year and other years to come. Thank you.
- CEO and Principal Consultant A Japan-based Leading Pharmaceutical Consulting Company
Thank you very much for the support. This was a totally a new process for us and we were plenty of doubts especially when having strong comments from other internal departments.
I’m sure Freyr’s team has learned a lot about how to get an accession number. That’s what is really important and gratifying. Thank you again and keep up the excellent work!
- Manager, Regulatory Affairs A Spanish Medical Devices Manufacturer
We have had a very productive year in preparing for our new products as a private label distributor. However, we could not have done it without the Freyr team. I wish entire team a joyous end of year and a happy and healthy new year. I look forward to catching up with you in the new year as we continue our efforts to provide quality generic drugs that have a history of drug shortage. Our plans are to move forward with another 20 products in 2020.
- Chief Quality & Regulatory Affairs OfficerA leading generic drug and pharmaceuticals company
On behalf of our team, I would like to thank the entire Freyr team for the services provided all through the year. Especially for the last few weeks, as we had so many urgent and important projects taking place, Freyr team’s on-time artwork delivery is commendable.
A team absolutely fantastic about turning things around. Truly your hard work and dedication is helping in getting more attention.
Thanks, and keep up the great work!
- Artwork Services Stakeholder A Switzerland based Leading Pharmaceutical Company
Thank you Freyr for all your help with informal testing, constructive feedback and positive engagement with CxRIM project!
- System Owner A British Multinational Pharmaceutical company
Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.
- System Owner A British Multinational Pharmaceutical Company
Completing the CTD writing project with Freyr was really helpful and cooperative. Despite the last-minute challenges and urgent requests, the Freyr team has managed to provide us solutions promptly without any setbacks.
- Assistant Manager | Global Regulatory Affairs A Global Bio-pharmaceutical Company
Thank you so much Freyr team for your support on the way in registering 3 of our medical devices in Philippines.
I hope this achievement will open numerous business opportunities for both Freyr and our company to work in synergy.
- Associate, Regulatory Affairs Team II, Clinical & Regulatory Affairs Center, A Korean Chemical Company
I would like to commend the Freyr team on their outstanding job to get 25 submissions out the door, on time. This shows that the team has put in extra efforts to tackle the additional task that was given to them on an ad hoc basis. I would like to appreciate the Freyr team for their great co-ordination and ability to handle large volumes of work effortlessly.”
- Associate Director, Global Regulatory Affairs Operations A Japan Based Leading Pharmaceutical Company
I am very pleased with Freyr’s performance. Even during high work pressure situation, the Freyr team did not hesitate to go an extra mile to complete the given submission on time. The team ensured smooth communication to complete the given tasks correctly as per the expectations of the company. Freyr also provided guidance for publishing activities to our in-house experts and helped solving our queries related to eSubmissions. The support of Freyr team is highly appreciated and I look forward to continue working with them in future, as well.
- Manager Regulatory Operations A Japan Based R&D Driven Specialty Pharma Company
On behalf of myself and my organization, I would like to take this opportunity to express our thanks to one of the Freyr’s resources, for his hard work. He worked extremely hard, diligent, and effective in helping us putting together the ANDA. He has exceeded our expectations.
We have noticed that his knowledge in the Pharma industry has significantly grown when compared to his previous visit to our organization. He illustrated stronger leadership personality and logical approach which coincided well with our team. My team and I enjoyed his time here, especially the day-to-day technical debates/discussions we had with him. He is extremely good at what he does and an open-minded individual. We had faced many challenges with this ANDA, but he kept his composure well and found a solution. It was truly a pleasure having him on site for the second time and we are very much appreciative of his hard work.
We look forward to working with him, and in fact with Freyr again in the future.
- Senior Director of Business and Product Development A specialty pharmaceutical company
Thank you Freyr for rapidly responding to our extremely pressing issue regarding SPL submissions. Though the requirement was on a short turnaround time failing which the application to FDA was to be cancelled, you guys have worked it out without compromising. We are extremely happy to see your rapid response in sharing the package to FDA. The entire Freyr team is to be congratulated on being able to provide an important service in a very short period of time. Again, thank you for the unbelievably rapid response to our pressing request.
- Associate Director, Global Regulatory Affairs A Global Specialty Generic Pharmaceutical Company
I would like to commend the Freyr team on their outstanding job to get 25 submissions out the door, on time. This shows that the team has put in extra efforts to tackle the additional task that was given to them on an ad hoc basis. I would like to appreciate the Freyr team for their great co-ordination and ability to handle large volumes of work effortlessly.
- Senior Director of Business and Product Development A Specialty Pharmaceutical Company
We would like to express that we are very happy with Freyr's servcies. Freyr's resources did a good job both qualitatively and quantitatively. We are looking forward to work with Freyr on more projects in future.
- Vice President, Regulatory Affairs An India-based Multi-faceted Healthcare Organization
This is really great and very much appreciated! I’m aware that the latest period has been a bit hectic for everyone and I’m happy that you have pulled it off as a team, doing your best to succeed. I hope that all the future operations will go smoothly as well. Many thanks again and best regards!”
Thank you very much for all of your hard work with this IND! It is greatly appreciated!
- Senior Regulatory Affairs Specialist An American MNC For Health Information Technologies and Clinical Research
We would like to thank Freyr for successful submission of our IND. Given our timelines it was a challenging task and I appreciate Freyr’s responsiveness and professionalism that they showcased throughout the project.
Thanks again, we look forward to continuing our collaboration.
- Vice President, Legal and Regulatory A Dynamic Contract Research Organization
Freyr’s Software Team is excellent in resolving issues, which are important to an FDA reviewer. Many thanks once again, kudos to your team.
- Senior Manager India based, Global Top Generic Pharma Company
Thank you for this excellent news and we would like to express our gratitude to the Freyr team for all the great work and expertise that they have brought to the project to make it a success!
- Senior Regulatory Affairs Officer A Global Industry Leader in Medical Device Design and Manufacturing
WHOW WHOW WHOW!!!!! YES YES YES!!!!! THANK YOU THANK YOU THANK YOU!!!!!!
This call for the celebration. Thank you for your consistency, perseverance and amazing team work at Freyr!!!! THANK YOU.
- Regulatory Affairs Officer A Global Industry Leader in Medical Device Design and Manufacturing
Thank you Freyr for handling complex submission with grace. The Russian Health Authority made a lot of requests which required multiple preparation meetings, as well as LEAD meetings. Freyr team handled it very well, especially given the limited turn-around time.
- Senior Specialist One of the World’s Largest Pharmaceutical Companies
We appreciate the great support received from Freyr for their successful communication with the FDA while offering extended support for transmitting submission and sharing the acknowledgments. Thank you for managing and completing the task in a very short period.
Awesome!!! Great Team work.
- Head – Global Regulatory Affairs An integrated pharmaceutical topical organization
Outstanding Freyr Team! You guys rocked!
Thank you for the awesome work that you guys have provided for both the projects Cosmetics and RI that both met the cost and project deliverables. We are extremely satisfied with the outstanding technical leadership, and the output that met our expectations.
Looking forward to partner with you for future projects.
- Global Regulatory Affairs, A World-wide Leader in Health and Beauty
I have to compliment Freyr for their knowledge and investigation that brought to light an obsolete label that had not been inactivated in the LAB database. They went and found the inactivation form! Made me wish I had thought of that. I really appreciate the time they always put in to answer my questions.
- Labeling Cluster Head Director, Global Labeling Management WRO, Worldwide Safety & Regulatory A leading Research-based Biopharmaceutical Company
Special thanks to Freyr team for their patience and co-operation while developing and customizing a leading workflow and content management solution for our requirements. With their collaboration we could have developed such a functional tool for docs sharing, submission management and status.
Kudos to entire Freyr team for their excellence. Keep up the good work.
- US based, Global, Pharma Company
We sincerely acknowledge and truly appreciate Freyr’s committed performance to meet our expectation and be at the highest peak consistently. We can always rely on Freyr’s products/services because we know even if there is any issue, you will resolve it certainly.
We look forward to work with Freyr for many years to come and will recommend Freyr as well.
Looking forward to another year of professional partnership and success.
Thank you very much for working with us on the India Cosmetic project. We appreciate your resource’s diligence and focus and attention to detail. Very lucky of you to have them in your team
- A Leader in Skin Health
We would like to express our deepest gratitude and appreciation to Freyr’s outstanding contributions to our company. We have been greatly benefitted of Freyr’s exemplary services and timely deliverance, in turns we could win our customer’s appreciations & heart and are able to achieve our Business Objectives. We owe part of our success to you.
We sincerely acknowledge and truly appreciate Freyr’s committed performance and their team efforts to put their best to meet our expectation and be at the highest peak consistently. We can always rely on Freyr’s products/services because we know even if there is any issue, you will resolve it certainly.
We look forward to doing business with Freyr for many years to come and will recommend Freyr to our clients, as well.
- Chief Human Resource Officer A Delhi-based Ayurvedic and natural beauty and wellness product company
We would like to thank Freyr’s resources for their: tireless efforts to support the regulatory submissions; efforts to reiterate the team’s goals by including reminders on response target; and for also highlighting the durations of task which we’ve been working on. We could not be as successful with our projects without the Freyr team! As always, we look forward to continued collaborations and endeavors with your team
- A U.S.A. based Generic Pharmaceutical Company
You have exceeded our expectations as a team and individuals! Special thanks for all the added prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively.
We really appreciate the efforts which have been taken by Freyr’s team in submission of PDE reports of requested products at very short notice period. We hope to receive the same support from your end for all future endeavors.
- An India-based Healthcare Organization
Awesome work! We are grateful for your support in achieving a key project milestone for pregnancy category designation removals for 317 USPIs identified as in scope.
-Business Support Admin IV – GLM WSR/Worldwide Regulatory Operations A Leading Research-based Biopharmaceutical Company
We appreciate Freyr’s efforts for quickly completing remediations for two important labels and bring them into alignment with the parent labels, following a summer intern project with respect to comparing private labels to primary labels.
- Business Support Admin IV – GLM WSR/Worldwide Regulatory Operations A Leading Research-based Biopharmaceutical Company
I completely echo my colleague’s sentiments! I don’t quite know how we managed it, but we did it. Freyr resource’s dedication and support over the past 9+ months is a testament to how great a team we have in GLM.
- Cluster Head - GLM (Global labeling management) A leading Research-based Biopharmaceutical Company
Post today’s GLM meeting, I just wanted to follow up quickly and personally THANK YOU for all Freyr resources’ hard work and their significant contributions to the PLLR Project. I realize it’s not over, but we successfully completed a major milestone – one that seemed shaky for a few months earlier in the year! As I said, this FDA compliance program has touched nearly everyone in GLM – a true team effort – but I realize you all, along with our in-house expert, did much of the “heavy lifting.”
- Executive Director - GLM (Global labeling management) A leading Research-based Biopharmaceutical Company
Thank you for the information!! Freyr is awesome at their job, I really appreciate Freyr’s insight and help.
- Regulatory Strategist A leading Research-based Biopharmaceutical Company
I just wanted to express my appreciation and gratitude for all the work that was put in for the safety labeling change. The RRT didn’t happen until Monday and Freyr’r resources were able to pull everything together and I know they worked long hours, even being online at 3 AM to attend a meeting. Freyr’s commitment and work ethic is truly amazing. Thanks for ensuring we were able to get this to publishing on time.
- Global Regulatory Affairs A leading Research-based Biopharmaceutical Company
Now that we have a few people having worked with Freyr on different projects, I wanted to share my feedback about our recent experience with the Freyr team. They have been very positive – they are easy to work with, and quick and willing learners. Some of the projects we’ve had them working on have been very complicated and large documents, and they have approached these in a very methodical stepwise way. Working with them has definitely freed up time for our LRRs, and we look forward to that continuing into the future.
- Regulatory Affairs Senior Manager An American multinational biopharmaceutical company
We are happy to share that as part of recognizing excellence in GLM and PPQ, one of the Freyr’s associates is awarded the Gold Star for the fantastic feedback from the Regulatory strategist regarding his work.
- A leading Research-based Biopharmaceutical Company
On a quick note, let me thank Freyr for their resource’s professionalism and hard work. I wanted to share that one of our colleagues from the internal development team reached out to me to let me know that she had a great interaction with your resource and she appreciated how knowledgeable he is and how well he explained next steps/demonstrated understanding of what was needed, etc.
I appreciate your resource’s support.
It was such a pleasure to finally meet the Freyr’s team in person. I am so happy I was able to visit the Freyr office. I am very impressed with the wide scope of Freyr's expertise and I am excited about their innovative plans and the future of our companies' collaboration. I would like to extend my heartfelt gratitude and appreciation to everyone for the wonderful reception we received and as always for all the Freyr’s hard work.
- Manager Labeling An American multinational biopharmaceutical company
This is my team and I am more than thankful to all for making this initiative a great success. Without Freyr’s hard work we wouldn’t have achieved what we have
- Director Labeling An American multinational biopharmaceutical company
A huge thanks to Freyr for the excellent support in turning around 100 (approx..) lit references which were needed in a short period in support of an New Drug Application (NDA) submission. Really appreciate Freyr’s dedication and hard work in making this possible. This is a critical submission for us and therefore I wanted to take the time to let you know that the submission team recognize your contribution and are extremely grateful for your support not only for these but also for the hundreds of reports which you’ve republished to make submission-ready for this major submission.
- Submissions Manager Switzerland based, Global Pharmaceutical Company
Thank you so much for working on these and making them a priority. Your help is truly appreciated.
- Product Manager Canada based, global pharmaceutical company
I am very impressed on how quickly you were able to process this request. This is a great example of excellent Customer service and striving to meet the upcoming process order for September 24.
- Graphics Project Leader Canada based, global pharmaceutical company
Many thanks for the approvals. At the same time, I would not miss this chance to thank each one of you for taking that extra step to make this happen in a time of emergency!! Much Appreciated!
- Assistant Manager – Packaging Designing Canada based, global pharmaceutical company
Thanks for turning this around so quickly! I kicked this off on Aug 23 (sent a proper GRF Aug 28) and in 3 weeks we now have new codes and a TT. That is AMAZING. Thank you for always pushing! Thank you for the fast turnaround with artwork creation and updates! I really appreciate this one!
- Coordinator, Marketing Canada based, global pharmaceutical company
Thank you very much for your tremendous efforts to follow up with CCRs and making sure none of them become overdue. Greatly appreciated!
- Supervisor, Change Management Canada based, global pharmaceutical company
Just wanted to thank everyone for their time and efforts to push this through to TT. Your time and assistance are sincerely appreciated.
- Graphics Manager | Global Regulatory Affairs Canada based, global pharmaceutical company
I am very impressed on how quickly you were able to process this request. This is a great example of excellent customer service and striving to meet the upcoming process order.
You’ve all been involved in making this possible in various capacities and as you know, there’re many more 2D converted products to come soon. Let’s keep up the great work. On my opinion, we’re all part of something special here. I can assure you that we have many pharmacists, physicians, nurses and patients that need this 2D technology and who will benefit from it ASAP. Thank you all for your patience and support.
- Trade Dress Manager, Marketing Canada based, global pharmaceutical company
Thanks for your support to complete labeling deficiency response in one day. It is really a great job and appreciable….
- Associate, Regulatory Affairs Canada based, global pharmaceutical company
I would like to take this opportunity to appreciate Freyr in working collaboratively during this important launch. Freyr has been fantastic in supporting us all the way, keep it up.
- Deputy General Manager | Regulatory Affairs Canada based, global pharmaceutical company
A huge ‘thank you’ to all those involved in the project for their extraordinary help in getting this artwork updated within such a short timeframe. This is greatly appreciated!
- Senior Regulatory Affairs Associate Canada based, global pharmaceutical company
I just wanted to say that this was nice customer service where you provided us with the visual of the label with 9 pt. (min font requirement) as well as the version with the 7 pt. That provided us the visual of what the label would look like with the reduced font. Best of customer service.
Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other points areas that you are thoroughly investigating, regarding the QA database etc.
We are excited about completing the filing of BLA. We would like to send Freyr team, a gift of gratitude for the late hour’s work
- DGM Regulatory Affairs NPD Canada based, global pharmaceutical company
We really appreciate your help and support in the preparation of artwork. We also thank the graphic artists for their spectacular efforts.
Thanks, Freyr team for all your efforts with this artwork update! Really appreciated!
- Coordinator, Global Supply Program Management Canada based, global pharmaceutical company
Thank you ALL for the time and the tireless effort that you all have invested into getting these upto the stage they are in! Freyr team - this has been a challenging project, thank you all for your patience and understanding.
- Regulatory Affairs Associate Canada based, global pharmaceutical company
Thank you, team, for your efforts in supporting several key launches over the last few months. Launches play a critical role in the growth of our business. Thank you to the entire team for your efforts and support in making our launches successful.
- Director Canada based, global pharmaceutical company
Thanks for the support to Tech transfer most of the Launch artworks. Freyr’s commitment and follow up in meeting the timeline is appreciable. Nearly Six Launch products were tech transferred during your visit. Thanks once again and hope we receive your continued support.
-Sr. Coordinator Canada based, global pharmaceutical company
Thank you very much. The illustration and detailed explanation on writing structure and presentation was well appreciated. Nice customer service!
“During the past several years, I’ve had the pleasure of working with Freyr Solutions in the publication, validation and electronic submission of regulatory documentation to the US FDA. The Freyr team had provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.”
- President Leading regulatory and quality consulting company
“We are excited about completing the filing of BLA. We would like to send Freyr team, a gift of gratitude for the late hour’s work”
- Head, Global Regulatory Affairs US based biotechnology company
Dear Freyr Team, “You are truly awesome. I make that <60 mins response time is marvelous. Thankyou everyone! Indeed, that was a fabulous job for the team.”
- UK Regulatory Operations Lead A Leading Pharmaceutical CDMO for APIs and finished dosage forms
“This is fantastic news! Thank you Freyr for your extraordinary efforts to complete this major milestone on time. Congratulations to the Core Team for your contributions to this achievement. The information that you generated through the development process and your assistance in pulling it together for this submission was amazing! It was very satisfying to read through the -2500-page document! ”
- Project Head, Vision Care Development Leading global eye care company
“We have accomplished one more major filing of PMA submission for devices on time. This submission US PMA (22nd April 2016) is one of our Milestones targeted for this year. Special note to mention that published output for this submission includes Paper Copy (-2500 pages) and eCOPY (150 document) which was independently handled by Freyr resource without any quality issues. Thank you for the outstanding work and quick turnaround to get it published on time which enabled project team to achieve the milestone. Keep up the good work going.”
- Global Franchise Head – Submissions Switzerland based, Global Pharmaceutical Company
“Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.”
- Senior Research Assistant US based leading biopharmaceutical company
“The Global Clinical Trial Application packages are now final (5 days prior to the agreed upon target dispatch of Sept 27) and have been dispatched to the CTLs and HUB (and out of HUB countries) to facilitate local health authorities and ethics committee submissions. We would like to take the opportunity to thank Freyr for valuable contributions towards this CTA package under the stretched timelines of this RACE program. We remain available for support with local HA submissions and queries to enable a successful FPFV.”
- Regulatory Lead – CTA (Clinical trials application) Switzerland based, Global Pharmaceutical Company
“Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified by the GRA Lead. This continuously demonstrates Freyr's commitment towards our company’s milestones, keeping the patient in mind.”
- Director Global Regulatory Affairs - Operations India based, Global top 5 Generic Pharma Company
I wish to place on record my sincere appreciation for getting us to this point with the CTD update for our product. Your diligence, thorough input and timely delivery of all requests have been noted and is greatly appreciated.
Thanks for your extreme support during submission. It’s my pleasure to work with you. Without your hard work and dedication to work I guess we could unable to complete the task on time. Best of luck for your future projects and appreciate your efforts!!!!
- Manager-Regulatory Affairs US based, Global, Pharma Company
overall it was great experience working with Freyr’s team and we were quite happy with the feedback the team has shared.
- GM (General Manager)- Global Clinical Development An India-based Pharmaceutical and Biotechnology company
Congratulation!!! Thanks for great Support for successful ANDA filing. Especially for publishing team heartfully appreciate their last hours’ hard work.
- Assistant Manager A Privately Held Pharmaceutical Research and Development Company
We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and also how we operate, it is possible to realise our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team!
- Operations Head A Privately Held Pharmaceutical Research and Development Company
I am very satisfied with Freyr's credibility in my interactions. I received good advice that I felt was very above board. We had previously employed a consulting group that specialized in policy strategy and found that Freyr was able to accommodate those needs but also get to the practical needs of preparing and filing our application with the FDA. This was very important to me, and means that I will use Freyr's services in the future. Speed of service, responsiveness, attention to my needs, quality of product, and price are all very important and I felt they were very good in my work with Freyr.
We had a transition from one team to another during the process and it worked out well. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. In our interaction, I received good suggestions and advice and the Freyr team was able to adapt to my needs. Because we are always working under time constraints, this was very important. I felt we were able to get up and running quickly and respond to shifts quickly. Any time I had a question or needed support, I got rapid response and good answers to my queries. Rapid responses and ability to shift direction when needed was very good. I thought the support was very good and met with expectations. In addition, found the price reasonable given the work load.
- Director, Regulatory Affairs US based leading precision medicine company
Wanted to share the good news that our BLA was accepted for filing by the FDA. We appreciate all of Freyr’s hard work that went into making this submission ACCEPTABLE!!
We have had a good impression of Freyr and feel more than comfortable telling partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly and we felt went along at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.
- Director, Regulatory Affairs US based a leading precision medicine company
Freyr’s resource has been a great asset to us in ensuring all the target deadlines for numerous submissions were met. The eCTD submissions continued to meet the quality standards. We truly appreciate all the work Freyr has done in the past 3 months. Thank you so much Freyr team for great efforts and keep up the same spirit.
- Regulatory Professional US based, Global, Pharma Company
Thank you so much for the receipt and ACK for this Submission. And thank you and all the Freyr team for all your hard work and long hours in getting this Submission out on time. It is greatly appreciated by everyone.
– US based, Global, full-service clinical research organization
Collaboration is a working practice whereby individuals work together to a common purpose to achieve business benefit. Collaboration enables individuals to work together to achieve a defined and common business purpose
On behalf of entire team, we would like to Congratulate both of the Freyr resrouces for getting nominated as “Values & Behavior Champion” for Excellent collaborative efforts and hard work while contributing on publishing activities irrespective of external factors influence which created some challenging situations. You guys were extremely productive & did not lose your focus. We appreciate your efforts for championing our organization’s Values & Behaviors and being a Role Model to your team.
This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided dedicated resources needed to meet our immediate regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided.
- Quality Control and Regulatory Manager US based, Global Innovator Products Manufacturer
We would like to appreciate Freyr for making us equipped with well-defined deliverables to the FDA. For their demonstration of 5-star support, we will use Freyr for our overflow of work. We truly believe in Freyr as a brand and as an expert provider of Regulatory services and look forward to work together on an on-going basis.
Terrific Job Freyr, GREAT TEAMWORK!!!
- Director of Regulatory Affairs-Operations, India based, Global 4+ Bn Pharmaceutical Company
During the past several years, I’ve had the pleasure of working with Freyr in the publication, validation and electronic submission of regulatory documentation to the US FDA. The Freyr team has provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.
- President, An Independent regulatory and quality consulting company
Freyr was a great find indeed. The Freyr Publishing team catered excellent Study Report publishing services. The icing on the cake was their proper coordination, flexibility, dedicated study team, timely and constant communication and subject matter expertise that added to the ease of doing business and towards successfully accomplishing the end goal. This, as well as the fair pricing, is what sets Freyr apart from their competitors. As always, I would recommend Freyr again with no hesitation and should the opportunity arise, we absolutely approach Freyr.
- Project Manager, A full-service Clinical Research Organization (CRO) Based in Florida
Under the EMA’s tight timelines, your resource has successfully delivered on commitments with overwhelming speed and decisiveness ensuring we met the requirements on time. We just wanted to recognize their hard work and diligence on the product information update for a drug. Within just few weeks of their stint at our organization, they successfully navigated our processes and integrated them into the product team. Quite impressive! We must reiterate!
- Senior Regulatory Associate, Worldwide Regulatory Strategy A leading research-based global Biopharmaceutical Company
On behalf of the entire team, I’d like to thank you for your hospitality. We understand that hosting us took time away from your day-to-day activities, and we just wanted to say thank you for everything you did to make this a very interactive, productive and successful visit for us. We would especially like to pass along our appreciation to the entire Freyr team for partnering in our mission to serve patients.
- Director, Supplier Performance Management, Global Regulatory Affairs & Safety Forbes Global Top 10 Biopharma Company
I approached Freyr with an issue we were having in quickly confirming the global acceptability of several new raw materials for use in our products. Within a few days, their team provided me with a comprehensive review by country citing regulatory references. The reports also included valuable additional information regarding cosmetic uses of the materials in various markets. For a very reasonable price, Freyr was able to provide our company with exactly what we were looking for.
– Director, Regulatory Affairs, US based, Cosmetics Manufacturing Company
We are making great progress and we are impressed with Freyr’s commitment to success and willingness to be flexible; you clearly have capable and experienced people in your organization.
– VP and Head of Regulatory Operations of a Global Top 5 Pharma & Consumer Company
We would like to congratulate Freyr team for their excellent service and error free XEVPRM submission with short notice and well within the regulatory timeframe. We sincerely appreciate their technical skills and their extraordinary and selfless effort.
We are pleased to acknowledge the timely support and recommend Freyr to everyone who are looking for such services.
– Vice President, Clinical Research & Pharmacovigilance, Microlabs
Thanks so much for all the help and diligence. We are so impressed by the way things have been handled by Fryer and the level of competence.
We have another very similar project coming up in the next few weeks where we need exactly the same level and type of service which we will be delighted to talk to you further.
– Program Manager, Regulatory Affairs – Global $1Bn Pharma Company
Thanks for the great work you are doing, sharing the great principles that Freyr uses for its employees and your focus on sustainability.
– Head of Procurement, Fortune 100, Global Top 10 Consumer Healthcare & Pharma Company
It has been an absolute pleasure working with Freyr over the past few months. Thank you very much for all the hard work – I could not imagine how difficult it would have been without the team being so proactive and diligent.
I look forward to returning to work with you in January and an exciting new chapter in our time.
– GRA Operations Program Manager, Top 5 Global Pharmaceutical Company
Overall the project has gone very well; with targeted submission numbers being achieved substantially ahead of the original plan.
- Associate Director, Fortune 100, Global Top 5 Consumer Healthcare Company
We have made great progress in a short duration and are impressed with the 162 positive acknowledgements from EMA for the XEVMPD submission project.
I would like to thank the entire team for their support for critical XEVMPD compliance activities.
- Program Manager, Global Top 5 Pharma and Consumer Health Company
I would like to thank the Freyr team for all the support they have provided. The Ops team is very satisfied with the level and quality of services from all the resources that we have on board.
Thanks to their commitment and discipline, we were able to deliver on all key objectives that had been outlined for us in 2014.
- Head of Regulatory Operations, Top 5 Global Pharmaceutical Company
Freyr provided assistance and the review was conducted thoroughly and rapidly. I also appreciate that the team called me this morning and walk me through the files. It is once again a pleasure working with Freyr.
Just wanted to say that the team are doing a great job. Please keep up the excellent work!
– Product Specialist Global Regulatory Affairs, Global Top 5 Healthcare Company
As we near the completion of a major filing, I would like to thank Freyr and recognize the team resource’s performance. It has been a great addition to our team and throughout all the projects, the involvement has been impeccable, illustrating not only professional demeanor, but in-depth skills, dedication, attention to details, willingness to switch gears and deliver timely results.
We recognize and acknowledge the exemplary performance and look forward to working together.
– Manager, Regulatory Operations, Global Top 20, $20+ Bn, Pharmaceutical Company
Freyr provided critical services to support the CTA approval of one of our Top 3 global oral care brand. The project management and team support was amazing. The quality, quick turnaround time, online submission and validation was remarkable. We successfully got the MHRA approval on the CTA. I want to thank the entire Freyr Team for their role in this.
– Regulatory Affairs Franchise Manager, Global Top 5 Consumer Healthcare Company
This has been a large team effort and the continued progress is appreciated. Many thanks to the Freyr team as they were integral over the last few months in helping to reach a critical project milestone. Excellent team work!!
– Program Manager, Global Top 5, $70+ Bn, Pharma & Consumer Healthcare Company
Freyr's Regulatory support for eCTD submission is enormous with a specialized tool for publishing and submission, Freyr SUBMIT. In a year long engagement with the organization, we are extremely satisfied with the quality of their work and knowledge of their resources and leadership.
- Associate Director, Regulatory Technology and Ops, Global Top 20 Pharmaceutical Company
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