Featured Testimonials
Michael Bellero

Sr. Director, Head of Regulatory Operations

Medicinal Products

Publishing and Submission

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!

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.

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.

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.

  • Michael Bellero

    Sr. Director, Head of Regulatory Operations

    Medicinal Products

    Publishing and Submission

    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!

  • 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.

  • 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.

  • 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.

  • 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.

  • Pascale LE BAUD

    Regulatory Affairs Associate - RA Department, France-based, Leading Synthetic Implants Manufacturing Company

    Medical Devices

    UKRP Support

    UK

     

    FREYR has accompanied us with the registration of several products on the UK market. They have always been quick to reply, attentive to our needs, a great source of Regulatory information and support. The price is reasonable compared with other similar service providers. We particularly appreciate the personalized quarterly and annual status reports that Freyr provides. When we call on FREYR, we know they will do their best to satisfy our needs, and that customer satisfaction is a priority.

  • Robert Menadue

    Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company

    Medical Devices

    Registration and AR Services

    Malaysia and Indonesia

     

    Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.

  • Sergey Burlov

    Quality Manager, Russia-based, Innovative SaMD Company

    Medical Devices

    Registration and LR Services

    Brazil

     

    We are impressed with Freyr’s support in providing us with quick and well-detailed solutions to our queries. Freyr’s constant support to adapt to ever-changing Regulatory conditions while providing support with any additional queries we had in a timely manner has truly impressed us.

  • 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.

  • 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!