Challenge
A Top 5 biopharma sought to shorten its market approval filing timeline by half. This goal required a complex, multi-year, cross-functional transformation across Clinical, CMC, Clinical, Safety, Data Science and Regulatory. The client needed a central PMO office to provide strategic leadership and coordinate this large-scale transformation program.
Approach
We analyzed the Critical Path from Database Lock to submission, identifying processes that introduced variability, risk, or timeline delays. We led cross-functional teams to develop streamlined processes and rolled them out across filing teams. This iterative work—supported by a central "program control center"—focused on accelerating key bottlenecks and instilling a mindset for sustainable change.
Impact
We successfully accelerated the filing timeline by 14 weeks and reduced filing performance variability by 54%. The transformation delivered $49M in revenue value per submission. We installed a centralized performance tracking and process network team for continuous improvement.
