Health Authority Interactions in Europe

Mastering Health Authority interactions is key to European market success, unlock this success with Freyr’s expert guidance and comprehensive support for EMA and regional authority engagements, streamlining approvals and minimizing delays across EU.

Health Authority Interactions in Europe - Overview

Health Authority interactions in Europe help in drug product approvals and can have a positive impact on the approval timelines and overall costs. This can include Regulatory agency interactions with the European Medicines Agency (EMA) and other regional Health Authorities (HAs) for EU and non-EU countries).

Contact with HAs (whether in writing, via teleconference, or face-to-face) must be conducted efficiently throughout the Regulatory process and lifecycle of a product. Health Authority interactions such as EMA pre-submission meetings and scientific advice meetings require careful planning so that they are requested at the most appropriate time and address all those points that enable applicants to proceed with their submissions.

Understanding HA expectations and identifying potential risks and weaknesses with Regulatory submission strategies are essential. Furthermore, preparing for appropriate risk-mitigation strategies can help minimize potential delays in Regulatory approval.

Freyr’s team is experienced in planning for Health Authority interactions/meetings and preparing the documentation required to make them successful. A thorough evaluation of the outcome of such meetings helps ensure that the Regulatory strategies are in line with the HA recommendations. Knowledge of different dosage forms, types of Regulatory submissions, and a proven track record in providing Regulatory support have made Freyr a preferred partner to global companies in supporting their initial and EMA pre-submission meetings and post-approval maintenance changes.

Health Authority Interactions in Europe - Expertise

  • Regulatory support for all types of medicinal product licenses (e.g., National, MRP, DCP, and Centralized).
  • HA query evaluation (including a review of the Regulatory submission to which the query relates).
  • Support in the preparation and execution of HA query-response strategies.
  • Preparation of HA response documents, including relevant scientific justifications.
  • Assessment of submission documentation, including initial applications and post-approval submissions (e.g., initial validation comments, response to the completeness assessment report, and response to the Information Requests [IRs]).
  • Assessment of post-approval submissions (e.g., variations of Types IA, IA, IB, and Type II, line extension applications, etc.).
  • Country-specific administrative data (Module 1) requirements.
  • Support in case of application rejection by Regulatory authorities.
  • Requesting scientific advice from the Regulatory authority before/during the submission.
  • Coordination and preparation support for HA scientific advice meetings.
  • EMA pre-submission communications (e.g., related to the formulation, Regulatory strategy, etc.).
Health Authority Interactions in Europe

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​