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.

  • DGM Regulatory Affairs NPD

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Thanks for your efforts and for getting this label done within a day. Good work! Your support is highly appreciated.

  • Associate, Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    We really appreciate your help and support in the preparation of the artwork. We also thank the graphic artists for their spectacular efforts.

  • Regulatory Affairs Associate

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Thanks, Freyr team, for all your efforts with this artwork update! Really appreciated!

  • Regulatory Affairs Associate

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Thank you ALL for the time and the tireless effort you all have invested into getting these up to the stage they are in! Freyr team - this has been a challenging project. Thank you all for your patience and understanding.

  • Regulatory Affairs (Formulation R&D)​

    US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development​

    Medicinal Products

    Medical Writing

    USA

     

    Thanks a lot for your extended support at the last moment.We appreciate your amazing dedication and efforts.​

  • Chief Quality & Regulatory Affairs Officer

    US-based, Leading Generics Pharmaceuticals Company

    Medicinal Products

    Artwork

    USA

     

    Thank you. This entire pandemic experience is a very strong validation of the Civica model/mission. These are challenging times in the United States and around the world. We are proud to support US health systems and the patients they serve in this time of crisis and beyond. Thank you for your continued support.

  • Senior Coordinator

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Thanks for the support to Tech transfer most of the Launch artworks. Freyr’s commitment and follow-up in meeting the timeline are appreciable. Nearly Six Launch products were tech transferred during your visit. Thanks once again, and I hope we receive your continued support.

  • CEO

    US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development

    Medicinal Products

    Artwork

    USA

     

    Many thanks for your efforts, especially at the last minute.

  • Sr. Director, Combination Products

    Bermuda-based, Biopharmaceutical Company

    Medicinal Products

    Artwork

    USA

     

    It was a very good first engagement with Freyr Solutions. Given their remarkable efforts in all aspects, from solutioning to operational expertise to compliant transition, we are looking forward to working with them on future programs as well.

  • Senior Manager, Quality Systems

    Australia-based, Leading Biotechnology Company

    Medicinal Products

    Artwork

    Australia

     

    Thank you once again for the quick turnaround on these labels, much appreciated.