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Partnering with Your CDMO for CMC Preparation
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Collaborative partnering between Contract Development and Manufacturing Organizations (CDMO) and the drug product submission applicants (Applicant) 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.