Health Authority interactions/Pre-submission meetings - Overview
Health Authority (HA) 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, 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.
HA interactions and pre-submission meetings allow the applicant to interact with the HAs 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 HA 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 HA interactions during the product development lifecycle and navigate towards a successful outcome for Regulatory approval.
Health Authority 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 HA requirements
- Support in preparing for HA meetings and other Regulatory agency interactions
- Comprehending the Regulatory needs of customers for tailormade solutions
