Process Optimization and Design for Manufacturability
Most quality assessment today relies on end-product testing. However, the future of CMC review is based on Quality by Design (QbD), and the CMC Regulatory Decision is based on CMC Quality & Performance.
Based on our commercial production experience, we can provide advice on “Design for Manufacturability” and solutions to provide cost effectiveness in your final product. An optimized formulation assures efficient technical transfer, optimal stability and scalability.