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.

  • System Owner​

    UK-based, Multinational Pharmaceutical and Biotechnology Company​

    Medicinal Products

    Regulatory Affairs

    UK

     

    Thank You, Freyr team, for a Fantastic 2019! The OTC DOCS TD user community feels better supported despite the technical challenges and system constraints. Thank you for being the voice to represent their ways of working and helping us design a more user-friendly and effective system going forward. ​

  • Assistant Manager | Global Regulatory Affairs​

    South Korea-based, Global Biopharmaceutical Company​

    Medicinal Products

    Regulatory Affairs

    South Korea

     

    Completing the CTD writing project with Freyr was really helpful and cooperative. Thank you very much for your support and effort. Freyr Solutions very well understand the 'Asian culture'; sometimes, we ask for completing the project in stringent timelines, but Freyr accepts this kind of urgent request and completes them on time. ​

  • CEO

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

    Medicinal Products

    Regulatory Affairs

    USA

     

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

  • SVP - R&D ( Finished Dosage Form)​

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

    Medicinal Products

    Regulatory Affairs

    USA

     

    Kudos to you all for the brilliant teamwork!!! Alone, we can do so little; together, we can do so much. Look forward to the next milestone and collaboration on new projects in the future.​

  • Regulatory Affairs (Formulation R&D)

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

    Medicinal Products

    Regulatory Affairs

    USA

     

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

  • Vice President R&D​

    Canada-based, Leading OTC Products Company

    Medicinal Products

    Regulatory Affairs

    Canada

     

    Thanks for sending the invoice. The activities and amounts generally mesh with our expectations. The provided resource is doing a great job managing our projects and keeping us informed of the status. We are very happy with her diligence, professionalism, and high level of service. For tracking these types of hourly activities in our internal records, it would be helpful if you could provide a summary of the hours by month or by country if that is possible.​

  • Regulatory Affairs Manager​

    US-based, Leading Pharmaceutical-grade Chemicals Manufacturing Company

    Medicinal Products

    Regulatory Affairs

    USA

     

    I honestly can't think of any suggestions for improvement at Freyr's end. As I've said before, Freyr is terrific to work with, more so than any other consultant I've dealt with. Freyr's team was all incredibly responsive, helpful and met every timeline as they stated originally. I was very impressed with the team's professionalism and kindness. I mean it when I say I hope to work with Freyr on additional projects. I'll be reaching out to the team soon with details of future projects. ​

    Thank you, everyone at Freyr, for your excellent efforts – it is sincerely appreciated!

  • Regulatory Consultant​

    US-based, Leading Pharmaceuticals Manufacturing Company​

    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.

  • System Owner​

    UK-based, Multinational Pharmaceutical and Biotechnology Company​

    Medicinal Products

    Regulatory Affairs

    UK

     

    Thank you, Freyr, for all your help with the informal testing, constructive feedback, and positive engagement. ​

  • Quality Control and Regulatory Manager​

    US-based, Nutraceutical Products Manufacturing Company​

    Medicinal Products

    Regulatory Affairs

    USA

     

    This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours, and notifications of changes were promptly provided. This project is not yet complete but has been very successful until this point. ​