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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
Innovative, and cost-effective Regulatory artwork design & pack management services and software to support new product launches and brand re-designs... 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 SUBMIT 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 LABEL is a complete information management solution to streamline the Regulatory Labeling practice of any size in a company. Right from tracking and managing CCDS deviations, CCDS updates and development to creating and implementing local labels as well as custom reporting, Freyr Label is an end-to-end solution that puts companies in total control of all their Labeling compliance needs.
Freyr eTMF is a ready-to-use, simple, efficient and secure cloud-hosted, pay-as-you-go solution for companies to efficiently manage their costly, complex and global clinical trial data across the lifecycle. Freyr eTMF offers enterprise-class benefits in a cost-effective, on-demand suite to meet the unique and demanding TMF needs of small-medium CROs as well as large fortune companies.
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 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.
Freyr IDMP is an intuitive, user-friendly, and on-demand web-based solution with state-of-the-art navigation that supports consolidating, cleaning up, updating, authoring, approving, publishing, and archival of information in a standardized and structured format. Freyr IDMP efficiently monitors, tracks, updates and creates XML files that are compliant with EMA's IDMP requirements.
Freyr INSIGHTS 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 INSIGHTS 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’s EudraVigilance Medicinal Product Dictionary (EVMPD) Data Management Services include a comprehensive strategy from organization readiness assessment, development of implementation road-map to end-to-end process implementation.
Catering to worldwide Regulatory requirements with regional expertise across 120+ countries.
Radically redefining the global Regulatory solutions and services landscape for Bio-Pharma (Innovators / Generics), Consumer Healthcare and Medical Device companies.
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 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.”
- 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.
- Regulatory Manager Global Top 5, Pharma & Consumer Healthcare Company
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
This project was against a very tight schedule and required dedicated resources. Freyr provided the 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. This project is not yet complete, but has been very successful at his point.
- Quality Control and Regulatory Manager US based, Global Innovator Products Manufacturer
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 the 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. This project is not yet complete, but has been very successful at his point.
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
I highly recommend Freyr for any of your special needs. They have assisted my company with multiple submissions. They have kept to the established timelines each time and kept working to make sure we got the submission correct and in the shortest amount of time.
– CEO, J.A.R. Labsy
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
Great company for eCTD and regulatory supporting is Freyr. I am approaching the end of our first year engagement and we are extremely satisfied with the quality of their resources and leadership. They also have their own suite of tools for publishing eCTD and from what I have seen they offer a very viable publishing solution.
- Associate Director, Regulatory Technology and Ops, Global Top 20 Pharmaceutical Company
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