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.

  • Regulatory Specialist

    US-based, Leading IVD Manufacturing Company

    Medical Devices

    MOH account creating support in UAE

    USA

     

    “Freyr truly exceeded all our expectations and went above and beyond what we asked. Most remarkable is the staff’s quick response time, as they literally seem to be working around the clock. It was an unexpected surprise to have a global partner that was responsive at all hours of the day to our questions and concerns.

    We appreciated that they were always truthful about lead times for queries, submissions, and document reviews. Freyr always delivered when promised, and frankly, the process was easier than we thought. It is very refreshing to feel Freyr’s personal touch, compared to the transactional nature of other consulting partners we have worked with in the past.”

  • Manager, Regulatory Affairs

    Spain-based, Leading Medical Devices Company

    Medical Devices

    RAD Safety Report

    Spain

     

    “Thank you very much for the support. This was a new process for us, and we had plenty of doubts, especially when having strong comments from other internal departments.

    I’m sure Freyr’s team has learned a lot about how to get an accession number. That’s what is really important and gratifying. Thank you again and keep up the excellent work!”

  • Director, Regulatory Affairs

    UK-based, Leading Global Medical device company

    Medical Devices

    Device registration

    UK

     

    “On behalf of Livanova, I would like to thank you, Nisha Vempalle, and her team for the accurate advice and performance, the great commitment, and timely support in successfully completing the MHRA registration process during Y2021 for more than 700 devices. We also appreciate the way you accommodate all Livanova requests in a relationship of mutual trust and respect”.

    We are very satisfied with collaborating with you; looking forward to working with you in Y2022.

  • Associate Director

    US-based, Global Largest Pharmaceutical Company

    Medicinal Products

    Artwork

    USA

     

    I am writing to offer feedback on our Freyr partnership. I want to start off by telling you how much I have enjoyed this partnership. I have not had the opportunity to engage in this type of business activity prior, so all of this was very new to me. From day one, I knew that we would be great FOLs as we lead this team!

  • Graphics Manager | Global Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Thank you very much. The illustration and detailed explanation on the writing structure and presentation was well appreciated. Nice customer service!

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.