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Biologics License Application (BLA) – Overview

Through the BLA, promising biological medicinal products can be developed and approved to prevent and treat a wide range of serious, chronic diseases and conditions. That is why biopharma companies are working on new biological products to fill a void in the healthcare industry. Applicants face a difficult decision when deciding on a development strategy for submitting a Biologics License Application (BLA) to the US Food and Drug Administration (FDA).

Health Authorities (HAs) have begun implementing risk-based review procedures in response to the increasing regulatory enforcement for complex biologics/biosimilars and advanced therapies like cellular and gene therapy products. Because of this, an extensive list of complex submission requirements has been issued. Therefore, there is always the risk of failing to include all required details in the Biologics License Applications, which could result in a refusal to file (RTF) with the US Food and Drug Administration. As a result, BLA sponsors favor collaborating with a Regulatory partner with experience providing Regulatory consulting services for biologics and biosimilar products.

From pre-BLA/BPD meetings to post-approval Lifecycle Management (LCM) activities, E&E Medicals provides full regulatory support to BLA sponsors.

Biologics License Application

Pre-submission and strategic guidance in determining the best route for BLA submission to regulators.
Help from regulators in setting up meetings with the Food and Drug Administration (Type A, B, C, and BPD meetings for biosimilars).
Regulatory gap analysis, which includes data/analytical similarity assessment and regulatory strategy.
Several forms of Biologics License Application packages for various biological/biosimilar products were compiled, reviewed technically, finalized, and submitted (vaccines, recombinant therapeutic protein products, monoclonal antibody products, cellular and gene therapy products, etc.).
Requests for accelerated review and other regulatory services related to the development of biologic drugs (Fast-track, Breakthrough Therapy, Accelerated Review, and Priority Review).
Cell therapies, therapeutic tissue engineering products, and human cell and tissue products may apply for RMAT status.
Approach responding to FDA questions about HA, including how to write a Complete Response Letter (CRL) and when to send it.
Help from the regulators when submitting LCM data after approval (e.g., CBE 30s, annual BLAs, PASs, etc.).

Biologics License Application

Helping with the BLA Submission Process.
Providing sponsors with FDA BLA Guidance.
Help with submitting a BLA to regulators.
Scheduling BLA Meetings.
Help in Submitting a Completed Application for a Biologics License on Time.