Global Health Authorities-Specific Services

Freyr is the leading provider of Regulatory and medical affairs services for all categories of medicinal product registration and lifecycle management. Freyr’s Regulatory experts have real-time experience in getting end-to-end registrations done for medicinal products, especially with the major health authorities (HAs)-US FDA, EMA, and Health Canada. This will help the sponsors and manufacturers with hassle-free registration of medicinal products with the global HAs that include major countries, thus enabling a smooth launch and maintenance of the product in the market.

Overview

Navigating the complex Regulatory landscape of the life sciences industry requires industry insights coupled with unparalleled expertise. We at Freyr provide comprehensive Regulatory services globally, ensuring that your medicinal drug products (pharmaceutical (Rx/OTC), biologicals) comply with stringent Regulatory requirements, and current recommendations and achieve successful approvals and market entry.

We specialize in providing Regulatory expertise for the US FDA, EU, and Health Canada, our team offers end-to-end support to streamline your product's journey from development to market entry and beyond.

Our services encompass technical review, finalization, and submission of complete Regulatory packages, ensuring compliance with global standards and specific HA requirements. Our pre-submission support includes Regulatory strategic submission plans, Regulatory roadmap, and comprehensive reviews to ensure all Regulatory requirements are met. Freyr extends support with regard to clinical, non-clinical, Labeling, Artwork, Pharmacovigilance, and electronic Publishing and Submission domains to provide end-to-end registration support.

Global Health Authorities-Specific Services

  • Providing strategic Regulatory consultation
  • Drawing Regulatory roadmaps/ pathways
  • Strategic guidance during the development stage of the medicinal products
  • Preparing and submitting pre-submission meeting packages
  • Leading and participating in health authority interactions
  • Gap analysis of source documents and providing mitigation guidance for identified gaps
  • Authoring of CTD/non-CTD dossiers in line with country-specific requirements
  • Providing strategy and preparation of response package to HA deficiencies
  • Control assessment and global post-approval submission strategy
  • Review and preparation of post-approval variation packages
  • Preparation and submission of life cycle management submissions like annual reports and renewals
  • Authoring of administrative submissions
  • Expert registration support for all types of medicinal products, including biologicals, prescription and OTC pharmaceuticals, innovator and generic drugs, combination products, APIs, excipients, and package materials across all therapeutic categories
  • Expert registration support for all dosage forms, such as orals, injectables, ophthalmics, otics, topicals, transdermal patches, inhalers, aerosols, and drugs in all therapeutic categories
  • Utilization of in-house developed automation tools to enhance submission accuracy and efficiency
  • Proficient in handling end-to-end Regulatory registration activities
  • Complete ownership by Freyr for successful registration and approval
  • One-stop solution for all Regulatory registration activities
  • Extensive support for expedited review programs and special Regulatory designations

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​