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.

  • Associate Director

    US-based, Global Largest Pharmaceutical Company

    Medicinal Products

    Artwork

    USA

     

    Freyr’s resources are confident in calling out issues, discrepancies, and items needing attention.

    I look forward to working with the rest of the team – I am grateful to be able to provide feedback and look forward to this sharing often.

    I truly believe it assists us in building a strong and capable team.

  • SVP - R&D ( Finished Dosage Form)

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

    Medicinal Products

    Artwork

    USA

     

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

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

  • Senior Medical Director, Therapeutic Area Lead​

    US-based, Multinational Pharmaceutical and Biotechnology Company​

    Medicinal Products

    Medical Writing

    USA

     

    Thank you very much for your note and kind words. Working with you was an absolute pleasure, and I wish you all the best in your next endeavors! Thank you for your meticulous work and support through many projects while some of them very challenging, and for your valuable contributions to achieving our goals! You will be missed, but I am hopeful our paths may cross again sometime in the future.​

    Stay safe and healthy.

  • CEO

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

    Medicinal Products

    Medical Writing

    USA

     

    Many thanks for your efforts, especially at the last minute.​

  • Regulatory Affairs (Formulation R&D)​

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

    Medicinal Products

    Medical Writing

    USA

     

    Thanks a lot for your extended support at the last moment.We appreciate your amazing dedication and efforts.​

  • 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.

  • 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, 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!​

  • 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. ​

  • Trade Dress Manager, Marketing

    US-based, Leading Generics Pharmaceuticals Company

    Medicinal Products

    Artwork

    USA

     

    We want to thank the entire Freyr team for the excellent Regulatory support and customer service provided to us. It was all your hard and smart work that enabled our organization to get our product approved on time, and for that, we are very thankful and grateful to work and collaborate with Freyr as a preferred partner. Being a preferred partner, I hope we continue to have effective and efficient cooperation and collaboration in getting more products approved. Let us move forward to achieve more together.