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 - 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 by the GRA Lead. This continuously demonstrates Freyr's commitment to our company's milestones - keeping the patient in mind. ​

  • Manager-Regulatory Affairs​

    US-based, Leading Generic Pharmaceutical Company​

    Medicinal Products

    Regulatory Affairs

    USA

     

    Thanks for your extreme support during the submission. It’s my pleasure to work with you. Without your hard work and dedication to work, I guess we could not have completed the task on time. ​

    Best of luck with your future projects, and I appreciate your efforts!!!

  • Quality Control and Regulatory Manager​

    US-based, Nutraceutical Products Manufacturing Company​

    Medicinal Products

    Regulatory Affairs

    USA

     

    This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours, and notifications of changes were promptly provided. This project is not yet complete but has been very successful until this point. ​

  • GM (General Manager)- Global Clinical Development​

    India-based, Global Pharmaceutical and Biotechnology Company​

    Medicinal Products

    Regulatory Affairs

    India

     

    Overall, it was a great experience working with Freyr’s team, and we were quite happy with the feedback the team shared. ​

  • Director,​ Regulatory Affairs

    US-based, Leading Precision Medicines Development Company​

    Medicinal Products

    Regulatory Affairs

    USA

     

    We have had a good impression of Freyr and feel more than comfortable telling partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly, and we felt it went along at a reasonable pace. The team was knowledgeable, friendly, and accommodating. Rapid response is appreciated. Keep up the good work. ​

  • 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.

  • Global CMC Technical Lead​

    China-based, Leading Innovator Pharmaceutical Company​

    Medicinal Products

    Regulatory Affairs

    UK

     

    We are extremely happy to inform you that the BLA was successfully submitted to the FDA. We convey our sincere gratitude to the Freyr team, who worked diligently, tirelessly, and very closely with our teams over the past several months to accomplish this monumental feat on a timely basis. Freyr’s team went beyond the call of duty to make this BLA submission come true. We truly appreciate Freyr’s flexibility and eagerness to work with us to accomplish aggressive goals.

    ​ Look forward to your perennial support and our continued relationship and

  • 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!

  • CEO

    US-based, Leading Innovative Pharmaceuticals Company​

    Medicinal Products

    Regulatory Affairs

    USA

     

    Thank you all for the great support!​

  • Assistant Manager​

    US-based, Leading, Complex Generic Pharmaceutical Products Company​

    Medicinal Products

    Regulatory Affairs

    USA

     

    Congratulations!!! ​

    Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.