How to Avoid Last-Minute CMC Roadblocks to Approval (Oct 2023)

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Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. Unfortunately, as time passes, there is an increased risk of CMC issues becoming more complicated, time-consuming, and expensive to fix. Learn how to avoid these roadblocks by reading this white paper from Societal™ CDMO.