Explore: Biological Licence Application (BLA) | Clinical Trial Application Dossier | Narratives | New Drug Application (NDA) | Pregnancy Prevention Plan (or Programme, PPP) | Product Information (PI) | Statistical Analysis Plan (SAP) | Summary of Product Characteristics (SmPC) | United States Prescribing Information (USPI)
Biologics Licence Application (BLA)
- A BLA is the request for marketing 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.