Case Study
5 September 2025
Accelerated submission in rare disease: A Fortrea FSP case study
A small U.S.-based biotech company that’s focused on rare disease treatment needed to accelerate their Biologics License Application (BLA) submission timelines. With Fortrea’s Functional Service Provider (FSP) experience added to their team, they successfully met complex regulatory demands, rapidly scaled global resources and completed their accelerated submission on schedule.