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Collaborative partnering between Contract Development and Manufacturing Organizations (CDMO) and the drug product submission applicants is becoming increasingly important with the emphasis on product design by regulatory agencies.
The CDMO can provide the appropriate resources to build the scientific knowledge base for the product and the depth of science-based information for the drug design and development that are required in the CMC sections of the application. This Insight Guide provides some key benefits to partnering with a CDMO for CMC preparation.