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 Affairs Officer

    UK-based, global Medical Device Manufacturing company

    Medical Devices

    Device Registration

    UK

     

    You have exceeded our expectations as a team and 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.

  • Lead - Regulatory Affairs

    Lead - Regulatory Affairs, Russian Medical Device Manufacturer

    Medical Devices

    Registration and LR services

    Global

     

    Freyr has been our reliable Regulatory partner and possesses deep understanding of the technical documents. Freyr has provided us timely support for gap analysis which led to timely registration. We are highly impressed with the customer support we received from Freyr in understanding our queries and providing us timely and accurate resolution.

  • 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.

  • 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.

  • Robert Menadue

    Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company

    Medical Devices

    Registration and AR Services

    Malaysia and Indonesia

     

    Freyr provides a 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 acts professionally to execute the work with excellent communication of progress.

  • Sergey Burlov

    Quality Manager, Russia-based, Innovative SaMD Company

    Medical Devices

    Registration and LR Services

    Brazil

     

    We are impressed with Freyr’s support in providing us with quick and well-detailed solutions to our queries. Freyr’s constant support to adapt to ever-changing Regulatory conditions while providing support with any additional queries we had in a timely manner has truly impressed us.

  • Pascale LE BAUD

    Regulatory Affairs Associate - RA Department, France-based, Leading Synthetic Implants Manufacturing Company

    Medical Devices

    UKRP Support

    UK

     

    FREYR has accompanied us with the registration of several products on the UK market. They have always been quick to reply, attentive to our needs, a great source of Regulatory information and support. The price is reasonable compared with other similar service providers. We particularly appreciate the personalized quarterly and annual status reports that Freyr provides. When we call on FREYR, we know they will do their best to satisfy our needs, and that customer satisfaction is a priority.

  • 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.