In the USA a Biologics licence is required under the Section 351 of the Public Health Service Act before a biological product is introduced into interstate commerce. A Biological Licence Application (BLA) is submitted to obtain the licence. Granting of the licence certifies that biological product is safe, pure, and potent; and 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 and 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 with the application process.

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 have a need for our services to assist you in applying for a BLA, please Contact Us.