Country-Specific Regulatory Services

Freyr’s strategic presence through established offices, infrastructure, and Regulatory experts in regions with unique Regulatory requirements covering almost every country on the globe helps us cater to country-specific local requirements for services. Thanks to our regional experts and in-house AI tools, which enable us to help our clients facing the real-time challenges of establishing themselves in the Regulatory region and country meet their business expansion needs with the following support:

1. Acting as a legal or local representative
2. Supporting our clients with Module-1 preparation in the regional language
3. Translating the documents and related content from English to the local language and vice-versa

Country-Specific Regulatory Services - Overview

Freyr provides comprehensive support to ensure that your products meet local Regulatory standards and achieve successful approvals through interactions and follow-ups with HAs on ever-evolving country-specific Regulatory requirements and regular dialogue to clarify the technical content, which helps expedite the review and approval. Our services allow you to meet dynamic and specific country-region requirements and ensure compliance.

Our country-specific Regulatory Services include:

  • Legal/Local Representation Services
  • Translations Services
  • Module 1–Administrative Services

Country-Specific Regulatory Services

  • Provision of legal/local representation to comply with local Regulatory requirements
  • Accurate translation of Regulatory documents to meet local language requirements
  • Ensuring compliance with the regional guidelines for document submission
  • Regular updates on Regulatory guidelines
  • Regulatory experts with fluency in the local language to interact with Regulatory bodies
  • Prepare or review a complete dossier to meet country-specific requirements
  • Preparation of Module-1 documents in the local language with scientific inputs
  • Presence of established regional offices to handle legal or local representation across the globe
  • A complete understanding of the ever-changing Regulatory requirements of each health authority
  • Regulatory experts with real-time experience in meetings/interactions with HAs
  • Translation services by qualified scientific translators to meet regional language requirements
  • End-to-end management of country-specific Regulatory submissions
  • Facilitating timely and successful product approvals

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

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.

Lynne McGrath

Regulatory Consultant

 

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.

Assistant Manager​

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

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative 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!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​