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.

  • Sr. Manager, Regulatory Affairs – Labeling and AdPromo

    UK-based, Multinational Pharmaceutical and Biotechnology Company

    Medicinal Products

    Promotional review

    USA

     

    Our AdPromo review relationship with Freyr is continuing to evolve as we move forward. The team is collaborative and responsive. We are happy to collaborate with you on this important program.

  • Business Development Team, FDF RoW market

    India-based, Multinational Pharmaceutical and Biotechnology Company

    Medicinal Products

    Conference Support

    India

     

    I wanted to thank you and all the team who have worked on this project around the clock. You and your team exhibited good time management and customer service skills throughout the project by promptly responding to our queries and accommodating multiple iterations of the design and content. all of this has led the project to be delivered within such short deadlines.

    Thank you once again and we look forward to working with you again when the opportunity presents itself.

  • Regulatory Affairs Officer

    UK-based, global Medical Device Manufacturing company

    Medical Devices

    Device Registration

    UK

     

    You have exceeded our expectations as a team and individuals! Special thanks for all the added prepared technical documentation!! What an effort, team! Again, many thanks for all the work and efforts put into this, moving forward positively.

  • Director - Global Regulatory Affairs – Operations

    India-based, Global Top Generic Pharma Company

    Medicinal Products

    Regulatory Affairs

    India

     

    Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

  • Lead - Regulatory Affairs

    Lead - Regulatory Affairs, Russian Medical Device Manufacturer

    Medical Devices

    Registration and LR services

    Global

     

    Freyr has been our reliable Regulatory partner and possesses deep understanding of the technical documents. Freyr has provided us timely support for gap analysis which led to timely registration. We are highly impressed with the customer support we received from Freyr in understanding our queries and providing us timely and accurate resolution.

  • Sr. Director, Head of Regulatory Operations

    Ireland-based, Global Specialty Pharmaceutical Company

    Medicinal Products

    Publishing

    UK

     

    I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

    Thank you Freyr team for a job well done!

  • Head of Quality Assurance

    Medicinal Products

    Medical Writing

    India

     

    A big thanks to Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward for a continuous business association with Freyr.

  • 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.