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, 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.

  • 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!

  • 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.