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Decoding China's Marketing Authorization Holder (MAH) System
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Expedited Product Classification and NIOSH Certification for N95 Respirator
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What our Clients Say?
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
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
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
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
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.
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
Many thanks for your efforts, especially at the last minute.
A Technology-driven Contract Research Organization (CRO)
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
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
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
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
We have had a good impression of Freyr and feel more than comfortable telling our partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly, and at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.
Director, Regulatory Affairs,
US based leading precision medicine company
Speed of service, responsiveness, attention to our needs, quality of product, and price are all very important and I felt they were very good in our work with Freyr. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. 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 medicine company
You have exceeded our expectations as a team and individuals! Special thanks for all the prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively. Thank you for your consistency, perseverance, and amazing teamwork at Freyr. 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!
Regulatory Affairs Officer
A Global Industry Leader in Medical Device Design and Manufacturing
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
Thank you very much for the support. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments.
Freyr has successfully obtained the accession number within a short timeline. 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
The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?
Director, Regulatory Affairs
US based top Sterilization company
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