Biologics License Application (BLA) Submissions

In the USA a Biologics license is required under the Section 351 of the Public Health Service Act before a biological product can be introduced into interstate commerce. A Biological License Application (BLA) is submitted to obtain the license. Granting of the license certifies that biological product is safe, pure, and potent, and that the facility in which it is manufactured meets standards designed to ensure that it continues to be safe, pure, and potent.

Examples of products needing BLA submissions include vaccines, allergenic products, blood products, and cellular & gene therapies. The BLA application process can be comprehensive and requires an extensive set of documents, but PSC can help you by making the application process as smooth as possible.

What is in a BLA?

  • Form FDA 356h
  • Manufacturer Information
  • Product/Manufacturing Information
    • Source material / raw material
    • Manufacturing process and controls
    • Formulation
    • Facility information
    • Contamination / cross-contamination information
    • Environment assessment or categorical exclusion
  • Pre-clinical Studies
  • Clinical Studies
  • Labeling

If you would like more information, get in contact with us directly here.