Handling Health Authority queries, pharma/Biological products

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 regulatory 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.