A Leading, Global, Regulatory Solutions & Services 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 labelling 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 labelling 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.

Labeling Cluster Head
Director, Global Labeling Management
WRO, Worldwide Safety & Regulatory
A leading Research-based Biopharmaceutical Company

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.

- Graphics Project Leader
Canada based, global pharmaceutical company

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.

- Graphics Manager | Global Regulatory Affairs
Canada based, global pharmaceutical company

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.

- Graphics Manager | Global Regulatory Affairs
Canada based, global pharmaceutical 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

- 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.

- Associate, Regulatory Affairs Canada based, global pharmaceutical company

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!

- Graphics Manager | Global Regulatory Affairs
Canada based, global pharmaceutical company

“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!!

-  Head, Global Regulatory Affairs
US based biotechnology company

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.

- Global Franchise Head – Submissions
Switzerland based, Global Pharmaceutical Company

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.

- Quality Control and Regulatory Manager
US based, Global Innovator Products Manufacturer