HA Interactions/Pre-submission Meetings

Freyr, a trusted Regulatory partner, excels in facilitating successful drug development by expertly navigating Health Authority interactions and pre-submission meetings, ensuring clear communication and strategic alignment throughout the Regulatory approval process.

HA Interactions/Pre-submission Meetings - Overview

Health Authority interactions and pre-submission meetings are key factors for successful drug development, speedy approvals, and uninterrupted commercialization of a medicinal product. When a sponsor or a Marketing Authorization Holder (MAH) submits a specific application for intended purposes, Health Authorities (HAs) evaluate the data and may revert with their concerns or HA queries. This happens if the submitted data is insufficient or requires any further clarification on the quality, safety, and efficacy aspects.

Health Authority interactions and pre-submission meetings allow the applicant to interact with the HAs and understand the HA requirements/opinions in a proposed Regulatory submission and explain the applicant’s rationale/strategy for the respective Regulatory affairs submission.

With a strong footprint in handling various Regulatory agency interactions and Health Authority meetings for different stages of drug development, approval, and post-approval changes, Freyr is a preferred global Regulatory partner for pharmaceutical companies.

Freyr has a strong Regulatory team that comprises ex-agency experts and senior industry professionals to support sponsors for various types of agency meetings (e.g., pre-IND, EOP, pre-NDA, pre-BLA, etc.) and Health Authority interactions during the product development lifecycle and navigate towards a successful outcome for Regulatory approval.

HA Interactions/Pre-submission Meetings

  • Proven track record in secure agency communications/controlled correspondences for several technical matters in the clinical, nonclinical, and CMC areas of future Regulatory submissions.
  • Evaluation of the sponsor’s developmental/scientific data and providing a strategy for agency interactions/pre-submission meetings during various stages of the product development lifecycle.
  • Preparation of pre-submission meetings for various HAs across the globe (US FDA - Type A, B, C meetings, BPD meetings for biosimilars, pre-ANDA meetings for complex generics, etc., EMA - scientific meetings, EMA pre-submission meeting, etc., and RoW - pre-CTA meetings and NMC meetings).
  • Strategic preparation, framing meeting questions on clinical, nonclinical, and CMC-related issues in the early development stage and the Regulatory submissions stage.
  • Preparation of meeting materials/Briefing Packages (BPs) for FDA pre-submission meeting.
  • Managing any HA queries/pre-submission meeting requests.
  • Facilitate meeting preparations/rehearsal and participation in agency meetings (F2F and Telecons) with sponsors/MAHs.
  • Collaborative preparation of meeting minutes and strategic support in implementing action items post the minutes.
  • Expert advice or guidance on Regulatory mitigation plans for the identified deficiencies.
  • In-house Regulatory experts with real-time experience in research, analytics, manufacturing, clinical, and nonclinical areas to help sponsors in their drug development programs.
  • Understanding and implementing Health Authority requirements.
  • Support in preparing for HA meetings and other Regulatory agency interactions.
  • Comprehending the Regulatory needs of customers for tailormade solutions.

Streamline Your Health Authority Interactions

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​