With the evolving Regulatory enforcement for advanced therapies such as cellular and gene therapy products and other complex biologics/biosimilars that require extensive evaluation of the quality, safety, and efficacy aspects of drug products, Health Authorities have started implementing risk-based review procedures for Biologics License Applications (BLAs) approval. As a result, there might be chances of missing out on mandatory information in the BLAs that could lead to a Refuse-to-File (RTF) action by the US FDA. Therefore, BLA sponsors prefer to be associated with a substantial Regulatory partner with significant experience in Regulatory consulting for Biologics and Biosimilar products.
Freyr assists sponsors with end-to-end Regulatory support for the BLA submission process, starting from pre-BLA /BPD meetings to post-approval Life Cycle Management (LCM) activities. Additionally, our experienced team members provide Regulatory support for marketing authorizations and relevant LCM for various biological products that are approved in both the Regulatory paths (i.e., 351(a) Innovator Biologics Regulatory pathway and 351(k) Biosimilar Regulatory pathway).
- Pre-submission and strategic support in identifying the optimal Regulatory submission pathway for BLA filing.
- Regulatory support in scheduling the BLA FDA meetings (Type A, B, C, and BPD meetings for Biosimilars) and various Agency interactions.
- Regulatory gap-analysis (review of developmental data/analytical similarity assessment data), preparation of Regulatory mitigation plans, and Regulatory strategy for both 351(a) BLA submission and 351 (k) BLA submission to avoid RTF challenges.
- Compilation, technical review, finalization, and submission of BLA package for several types of biological/biosimilars products (vaccines, recombinant therapeutic protein products, monoclonal antibody products, cellular and gene therapy products, etc.)
- Regulatory consulting on Biologics drug development programs and request for expedited review program designations (fast track, breakthrough therapy, accelerated review, & priority review).
- Request for Regenerative Medicine Advanced Therapy (RMAT) designation for cell therapy, therapeutic tissue engineering product, or human cell and tissue products.
- Regulatory strategy for HA queries, Complete Response Letter (CRLs), preparation, and on-time submission of responses to the US FDA queries.
- Regulatory support for submission of post-approval LCM submissions (supplements PAS, CBE 30, CBE/BLA annual reports).