Challenge
A rapidly growing mid-size biopharma company anticipated an increase in submissions, necessitating an end-to-end Module 3 Process Redesign. The goal was to remove Module 3 from the critical path of regulatory submissions and increase quality to reduce re-work and Request to Questions, thereby improving scalability and sustainability.
Approach
We facilitated workshops to map the current and desired future state process flow for Module 3. After conducting a gap analysis, solutions were created by partnering with key client SMEs and implemented as pilots across upcoming major submissions. The approach focused on driving upfront strategy and clarifying roles and responsibilities.
Impact
The project delivered a 50-day cycle time reduction and yielded 2,600 FTE Hours in productivity gains. The process harmonization and automation improved quality, increased employee satisfaction, and drove increased alignment and trust.
