At Cytovance Biologics, our emphasis on manufacturing process characterization, validation, and regulatory support are central pillars of our commitment to patient safety and our dedication to your success. Drawing on the cumulative experience gained with more than 350 APIs in clinical phase evaluation with multiple commercially approved products, we provide valuable input on your long-term design and regulatory strategy to minimize risk, timelines, and costs. We offer process characterization and subsequent process validation services using Quality by Design-based approaches that insulate your molecule from any unexpected roadblocks in the transition between phases of your project.

Partnering with the cross-functional experts at Cytovance ensures procedural and operational excellence with absolute regulatory compliance as your molecule progresses to market.