Analytical Method Development and Validation – A CDMO Perspective

Pharmaceutical drug product development can be an expensive and time-consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug product by regulatory agencies.

A contract development and manufacturing organization (CDMO) that understands customer needs, regulatory requirements, and has a proven track record for developing and validating analytical methods can minimize developmental costs and reduce the time to market.

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