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. Properly validated drug product characterization methods are necessary for regulatory filings, but can also reduce overall turnaround time during scale-up, clinical release and commercial release.
White Papers / Tech Papers
Analytical Method Development and Validation – A CDMO Perspective
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