Director, Regulatory Affairs
US-based, Leading Precision Medicines Development CompanyPharmaceuticals
Regulatory Affairs
USA
I am very satisfied with Freyr's credibility in my interactions. I received good advice that was above board. We had previously employed a consulting group that specialized in policy strategy, and Freyr accommodated those needs and got to preparing and filing our application with the FDA. This was very important to me, and 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 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 respond to shifts quickly. Anytime I had a question or needed support, I got rapid responses and good answers to my queries. Rapid responses and the ability to shift direction when needed were very good. I thought the support was very good and met with expectations. In addition, found the price reasonable, given the workload.
Director, Regulatory Affairs
US-based, Leading Precision Medicines Development CompanyPharmaceuticals
Regulatory Affairs
USA
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 it went along at a reasonable pace. The team was knowledgeable, friendly, and accommodating. Rapid response is appreciated. Keep up the good work.
GM (General Manager)- Global Clinical Development
India-based, Global Pharmaceutical and Biotechnology CompanyPharmaceuticals
Regulatory Affairs
India
Overall, it was a great experience working with Freyr’s team, and we were quite happy with the feedback the team shared.
Quality Control and Regulatory Manager
US-based, Nutraceutical Products Manufacturing CompanyPharmaceuticals
Regulatory Affairs
USA
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 until this point.
Manager-Regulatory Affairs
US-based, Leading Generic Pharmaceutical CompanyPharmaceuticals
Regulatory Affairs
USA
Thanks for your extreme support during the submission. It’s my pleasure to work with you. Without your hard work and dedication to work, I guess we could not have completed the task on time.
Best of luck with your future projects, and I appreciate your efforts!!!
Director - Global Regulatory Affairs – Operations
India-based, Global Top Generic Pharma CompanyPharmaceuticals
Regulatory Affairs
India
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 to our company's milestones - keeping the patient in mind.
Regulatory Affairs Senior Manager
US-based, Multinational Biopharmaceutical CompanyPharmaceuticals
Regulatory Affairs
USA
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 with 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 continuing in the future.
System Owner
UK-based, Multinational Pharmaceutical and Biotechnology CompanyPharmaceuticals
Regulatory Affairs
UK
Thank You, Freyr team, for a Fantastic 2019! The OTC DOCS 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 and effective system going forward.
System Owner
UK-based, Multinational Pharmaceutical and Biotechnology CompanyPharmaceuticals
Regulatory Affairs
UK
Thank you, Freyr, for all your help with the informal testing, constructive feedback, and positive engagement.
Regulatory Consultant
US-based, Leading Pharmaceuticals Manufacturing CompanyPharmaceuticals
Regulatory Affairs
USA
Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions; that was a first for me. So very responsive to my 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 my requests.
What a great team you have, Freyr.