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

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Thank you, team, for your efforts in supporting several key launches over the last few months. Launches play a critical role in the growth of our business. Thank you to the entire team for your efforts and support in making our launches successful.

  • 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 Associate

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

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

  • 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.

  • Graphic Manager/ Global Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating regarding the QA database, etc.

  • Graphics Manager | Global Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    I just wanted to say that this was nice customer service where you provided us with the visual of the label with 9 pt. (min font requirement) as well as the version with the 7 pt. That provided us with a visual of what the label would look like with the reduced font. Best of customer service.

  • Senior Regulatory Affairs Associate

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    A huge ‘thank you’ to all those involved in the project for their extraordinary help in getting this artwork updated within such a short timeframe. This is greatly appreciated!

  • Deputy General Manager | Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    I would like to take this opportunity to thank Freyr for working collaboratively during this important launch. Freyr has been fantastic in supporting us all the way. Keep it up.

  • Associate, Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Thanks for your support in completing the labeling deficiency response in one day. It is really a great job and appreciable.