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.

  • RA Assistant Manager South Korea-based

    Global Leader in Biomedical Devices and Aesthetics

    Cosmetics

    Product Classification, Product Registration 

    Thailand

     

    Thank you so much for the good news! We appreciate for Freyr’s work and effort for this project!

  • Regulatory Affairs Specialist

    US-based, Leading Skincare Products Manufacturer

    Cosmetics

    End-to-End Cosmetic Registration

    Malaysia

     

    This is wonderful news!  Thank you so much for all that you have done and continue to do for us; we really appreciate it. 

  • Chief Supply Chain Officer

    US-based, Leading Skincare Products Company

    Cosmetics

    Regulatory Operational Services & Support

    Global

     

    I hope it was very clear to the team yesterday how happy we are with the work you do for us. You are very appreciated!

  • Kenton

    US-based, Leading Consumer Products Company

    Chemicals

    Formulation Assistance

    Global

     

    Good Work! The support was unbelievably helpful and quite comprehensive.

  • Keelan Proctor

    UK-based, Multinational Consumer Goods Company

    Chemicals

    Supply Chain Regulatory Formulation Assessment

    Global

     

    Firstly, thank you for your ongoing support with the RFA review process! We've moved few steps forward recently, which is great to see!

  • Regulatory Affairs Officer​

    UK based, global Medical Device Manufacturing company​

    Medical Devices

    Technical Documentation

    UK

     

    You have exceeded our expectations as a team and as 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. ​

  • Regulatory and Quality Assurance Manager

    Regulatory and Quality Assurance Manager

    Medical Devices

    Registration and AR Services

    Australia

     

    Freyr provides a very 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 act professionally to execute the work with excellent communication of progress

  • General Director, Regulatory Affairs

    Russian Based Healthcare Software Development Company

    Medical Devices

    PR and LR service

    Russia

     

    As a customer of Freyr Software Services Pvt. Ltd, we would like to express our appreciation for the high-quality and efficient work performed by your team in preparation and support of the software registration process in ANVISA. It was made possible to complete the project on schedule and achieve its goal as a result of the presence of highly qualified specialists, an established feedback system, and prompt resolution of any emerging issues

    We look forward to further fruitful and mutually beneficial Cooperation.

  • Senior Director of Business and Product Development​

    US-based, Leading Innovator Pharmaceuticals Company​

    Medicinal Products

    Regulatory Affairs

    USA

     

    The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

    Thank you again, and we look forward to working with your team on the next project!

  • Director,​ Regulatory Affairs

    US-based, Leading Precision Medicines Development Company​

    Medicinal Products

    Regulatory Affairs

    USA

     

    I am very satisfied with Freyr's credibility in my interactions. I received good advice that was above board. We had previously employed a consulting group that specialized in policy strategy, and Freyr accommodated those needs and got to preparing and filing our application with the FDA. This was very important to me, and I will use Freyr's services in the future. Speed of service, responsiveness, attention to my needs, quality of product, and price are all very good in my work with Freyr.

    ​ We had a transition from one team to another during the process, and it worked out well. Service was delivered appropriately and in a timely fashion. Thankful to Freyr's responsive team because of which we could comprehend our unusual needs. In our interaction, I received good suggestions and advice, and the Freyr team was able to adapt to my needs. Because we are always working under time constraints, this was very important. I felt we were able to respond to shifts quickly. Anytime I had a question or needed support, I got rapid responses and good answers to my queries. Rapid responses and the ability to shift direction when needed were very good. I thought the support was very good and met with expectations. In addition, found the price reasonable, given the workload.