The development and implementation of analytical methods are essential for success at all phases of a molecule’s journey, from pre-clinical development, to clinical manufacturing and ultimately, commercialization.
The overall strategy for establishing the program, however, varies depending on the stage of your company and requires an appropriate balance of speed, risk and cost, all while ensuring quality.
Ultimately, your analytical package must be designed to mitigate the risks for key milestones.
In this ebook, our experts share critical success factors for your analytical program and describe strategies and their impact on speed to clinic, speed to market and risk.
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*The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.