Biologics License Application (BLA)

  • A BLA is the request for markting approval of a new biologic medicinal product in the USA.
  • Similar to an NDA, a BLA includes relevant clinical trial results and CTD documentation, as well as the Risk Evaluation and Mitigation Strategies (REMS) document.
  • Trilogy can advise on your documentation needs and offers the scientific expertise and industry experience required to provide the full range of documentation required for your submission.