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.
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.
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
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.
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.
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.
Director, Regulatory Affairs
UK-based, Leading Global Medical device company
Medical Devices
Device registration
UK
“On behalf of Livanova, I would like to thank you, Nisha Vempalle, and her team for the accurate advice and performance, the great commitment, and timely support in successfully completing the MHRA registration process during Y2021 for more than 700 devices. We also appreciate the way you accommodate all Livanova requests in a relationship of mutual trust and respect”.
We are very satisfied with collaborating with you; looking forward to working with you in Y2022.
Manager, Regulatory Affairs
Spain-based, Leading Medical Devices Company
Medical Devices
RAD Safety Report
Spain
“Thank you very much for the support. This was a new process for us, and we had plenty of doubts, especially when having strong comments from other internal departments.
I’m sure Freyr’s team has learned a lot about how to get an accession number. That’s what is really important and gratifying. Thank you again and keep up the excellent work!”
Regulatory Specialist
US-based, Leading IVD Manufacturing Company
Medical Devices
MOH account creating support in UAE
USA
“Freyr truly exceeded all our expectations and went above and beyond what we asked. Most remarkable is the staff’s quick response time, as they literally seem to be working around the clock. It was an unexpected surprise to have a global partner that was responsive at all hours of the day to our questions and concerns.
We appreciated that they were always truthful about lead times for queries, submissions, and document reviews. Freyr always delivered when promised, and frankly, the process was easier than we thought. It is very refreshing to feel Freyr’s personal touch, compared to the transactional nature of other consulting partners we have worked with in the past.”
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.