The appropriate and timely communication with Health Authorities (HAs) is a key factor for the speedy approval and uninterrupted commercialization of a medicinal product either during initial approval or during Life Cycle Management (LCM, i.e. through post approval changes submissions). When a Marketing Authorization Holder (MAH) or applicant submits an initial or post approval activity application, upon evaluating the submitted data HAs may revert with their concerns or recommendations, if the submitted data is insufficient or requires any further clarification or for any further commitments post approval to ensure quality, safety and efficacy of the product.
Either the Information Requests (IRs), Refuse to Review (RTR), or Request for Further Information (RFI), the expertise lies in understanding the concerns, response compilation while answering, so that it avoids further queries and delays in the approval procedures. While responding to HA queries, the communication can be done in different modes based on the procedural stage and severity of the queries raised by the HAs. To prepare the response, the applicant can communicate with HAs or the HA assessor (responsible for the submission) to understand the queries in detail and to brief or explain the strategy behind for respective submission.
With a strong footprint in handling HA queries for different types of products and formulations, Freyr is proven to be a preferred Regulatory partner across the globe. Freyr has strong Regulatory team that has a thorough knowledge and understanding about the types of formulations, types of the Regulatory submissions and has a proven track record in handling HA queries pertaining to initial submissions and post approval changes/LCM of the products or administrative queries.
- Initial query evaluation
- Review of the Regulatory submission on which query is/was received
- Preparing the Regulatory response strategy
- Support in discussion on action plan
- Preparation of complete response document for HA queries with scientific justification
- Initial assessment of the submission (initial / post approval submissions) E.g., initial validation comments, response to the completeness assessment report, response to the Information Requests
- Assessment of post-approval submission (CBE-30, Type IB and Type II variations, prior approval supplement, extension applications)
- Correspondence with the United States Food and Drug Administration (US FDA) for Drug Master File review
- Administrative data (Module 1) requirements that are specific for the national competent authority (e.g. MRP/ DCP submission procedures in Europe)
- Compilation of the justification in case of rejection of the submission procedure by Regulatory authorities
- Requesting scientific advice from the Regulatory authority before/during submission
- Pre-submission communications (specifically for US FDA and European submissions) to confirm the formulation combination and Regulatory strategy for example, controlled correspondence to US FDA
- With detailed Regulatory assessment of registered dossier, Freyr can provide open points/possible queries from HAs
- Minimized response time
- Effective strategies in-line with HA requirements
- Response preparation with scientific and logical references
- Regulatory experts with real-time experience in research, analytical, manufacturing and quality help in understanding the queries/questions better and provide suitable guidance