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.

  • 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.

  • SVP - R&D ( Finished Dosage Form)​

    US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development​

    Medicinal Products

    Medical Writing

    USA

     

    Kudos to you all for the brilliant teamwork !! Alone, we can do so little; together, we can do so much.

    Look forward to the next milestone and collaboration on new projects in the future.

  • Global CMC Technical Lead​

    China-based, Leading Innovator Pharmaceutical Company​

    Medicinal Products

    Medical Writing

    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 Bridgewater and Beijing teams over the past several months to accomplish this monumental feat on time. 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 beyond. ​

  • Director, Global Labeling Management – Labeling Cluster Head Global Product ​ Development, Global Regulatory Affairs

    US-based, Multinational Pharmaceutical and Biotechnology Company​

    Medicinal Products

    Medical Writing

    USA

     

    Thank you, Freyr team. I appreciate your professionalism, dedication, and hard work. You’ve gone above and beyond to ensure all deliverables were met ahead of schedule throughout the project and have done a great job managing a challenging group of products. I appreciate your attention to detail and follow-up on the large workload you’ve managed. It’s been a pleasure working with you, and I wish you and your family all the best in the future!​

  • Lead, R&D/Personal Care

    India-based, Multinational Consumer Goods Company​

    Medicinal Products

    Medical Writing

    Vietnam​

     

    Thank you so much for being a great partner in our Regulatory compliance journey.

    As Asian countries move towards having safety assessments as a key requirement, your support has helped us significantly in fulfilling those requirements well ahead of our competitors in Vietnam. ​

    In fact, I shared your contact with our regulatory officers so that they can share it across the industry if the safety assessments become necessary.

  • Director

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Thank you, team, for your efforts in supporting several key launches over the last few months. Launches play a critical role in the growth of our business. Thank you to the entire team for your efforts and support in making our launches successful.

  • Deputy General Manager | Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    I would like to take this opportunity to thank Freyr for working collaboratively during this important launch. Freyr has been fantastic in supporting us all the way. Keep it up.

  • Senior Regulatory Affairs Associate

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    A huge ‘thank you’ to all those involved in the project for their extraordinary help in getting this artwork updated within such a short timeframe. This is greatly appreciated!

  • Graphics Manager | Global Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    I just wanted to say that this was nice customer service where you provided us with the visual of the label with 9 pt. (min font requirement) as well as the version with the 7 pt. That provided us with a visual of what the label would look like with the reduced font. Best of customer service.

  • Graphic Manager/ Global Regulatory Affairs

    Canada-based, Global Generic Pharmaceutical Company

    Medicinal Products

    Artwork

    Canada

     

    Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating regarding the QA database, etc.