Appropriate and timely communication with Health Authorities (HAs) is a key factor for successful drug development, speedy approvals, and uninterrupted commercialization of a medicinal product. When a sponsor or Marketing Authorization Holder (MAH) submits a specific application for intended purposes, Health Authorities will evaluate the submitted data and may revert with their concerns or requests if the submitted data is insufficient or requires any further clarification on the quality, safety, and efficacy aspects to grant the approval.
Health Authority interactions and pre-submission meetings are crucial as they give the opportunity to the applicant to interact with HAs to understand the HA requirements/opinions in detail on a proposed Regulatory submission, and to explain the applicant’s rationale/strategy for the respective Regulatory affairs submission.
With a strong footprint in handling various Health Authority interactions and agency meetings for different stages of development, Freyr is proven to be a preferred Regulatory partner across the globe.
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 meetings, EOP meetings, pre-NDA, pre-BLA meetings, etc.) and other interactions during the product development life cycle and navigate towards a successful outcome for Regulatory approval.
- Proven track record in secure agency communications/controlled correspondences for several technical matters pertaining to clinical, non-clinical, and CMC areas of future Regulatory submissions.
- Evaluation of sponsor developmental data/scientific data and providing a strategy for agency interactions/pre-submission meetings during various stages of product development life cycle.
- Preparation of pre-submission meeting requests for various Health Authorities across the globe (US FDA - Type A, B, C meetings, BPD meetings for biosimilars, pre-ANDA meetings for complex generics; EU - Scientific meetings, etc; RoW- pre-CTA meetings and NMC meetings).
- Strategic preparation, framing meeting questions from clinical, non-clinical, and CMC related issues of early development stage and for commercial stage Regulatory affairs submissions.
- Preparation of meeting materials/Briefing Packages (BBs).
- Managing any HA queries/information request against a pre-submission meeting request.
- Facilitate meeting preparations/rehearsal and participation in Agency meetings (F2F, Telecons) along with sponsors/Marketing Authorization Holder.
- Collaborative preparation of meeting minutes and strategic support in implementing action items post the minutes.
- Expert advice or guidance on Regulatory mitigation plan for the identified deficiencies.
- In-house Regulatory experts with real-time experience in research, analytical, manufacturing, clinical, and non-clinical areas to help sponsors in their drug development programs.