Featured Testimonials
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Ed Venkat
Global CMC Technical Lead
Medicinal Products
Publishing and Submission
UK
We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.
Please keep up the great work as we have many milestones to achieve over the next year.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Lynne McGrath
Regulatory Consultant
Medicinal Products
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.
Director of Regulatory Affairs
France-based, Leading Global Supplier of Women Healthcare Products Company
Medical Devices
Publishing and Submission
USA
Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied.
Director
US-based, Leading Medical Equipment Company
Medical Devices
PAC application submission
USA
The team has always been very professional and supportive with our projects and inquiries. Communication is always timely. Knowledge of regulations, Open Communication, Timely followups with my team and Professionalism. I feel you all work around the clock as you are very responsive on our questions any time of day.
Regulatory Affairs Officer
US-based, Leading Medical Equipment Company
Medical Devices
Product assessment and due diligence
USA
Knowledgeable staff, good interpersonal skills and very responsive to requests
Managing Director
India-based, Leading Global Medical-Technology Company
Medical Devices
Device Registration
India
A good product is developed not only by a technology, but with the real science and its validation to the norms of regulations. We couldn’t have achieved it without your able guidance and experience.
Key Accounts Manager
China-based, Leading Medical Device Manufacturing Company
Medical Devices
Device Registration and LR services
Thailand
We appreciate the efforts and expertise of the Freyr team during the registration procedure. The accomplishment is ahead of schedule, which is really wonderful. Cost-effective and the service is nice. A timely response is to your advantage. Hope we can work together on other projects.
Associate, Clinical & Regulatory Affairs Center
South Korea-based, Leading Global Chemical Company
Medical Devices
Device Registration
South Korea
Thank you so much, Freyr team, for your support on the way in registering 3 of our medical devices in the Philippines.
I hope this achievement will open numerous business opportunities for Freyr and our company to work in synergy.
Regulatory Affairs Officer
UK-based, global Medical Device Manufacturing company
Medical Devices
Technical Documentation
UK
WHOW WHOW WHOW!!!!! YES, YES, YES!!!!! THANK YOU, THANK YOU, THANK YOU!!!!!!
This call for a celebration. Thank you for your consistency, perseverance, and amazing teamwork at Freyr!!!! THANK YOU.
Senior Regulatory Affairs Officer
UK-based, global Medical Device Manufacturing company
Medical Devices
Device registration
UK
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 they have brought to the project to make it a success!
Director, Regulatory Affairs
US-based, Leading Precision Medicines Development Company
Medical Devices
Device registration
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.
Director
US-based, Leading Precision Medicines Development Company
Medical Devices
DMF compilation and Submission
USA
I am very satisfied with Freyr's credibility in my interactions. I received good advice that I felt was very above board. 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.
Thankful to Freyr's responsive team because of which we could comprehend our unusual needs. 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.