Have you developed a strategy for registration stability batches that optimizes drug utilization and minimizes cost?

Have you set your commercial batch size based on long-term commercial forecasts generated from cross-functional assumptions?

Have you identified your commercial distribution lanes?  Do you have data to support global transportation?

Have you considered a clinical sample program?

Will your vendor network ensure quality, compliance and on time delivery of product?

Have you established a commercial readiness roadmap that leverages clinical supply data to eliminate redundant work in the commercial space?