Regulatory Manager: What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products Part 2: Clinical Transition From Phase 2 to Phase 3

| 01 September 2009

The transition from Phase 2 clinical trials (studies to evaluate the effectiveness of the drug for a particular indication in patients) to Phase 3 clinical trials (expanded studies intended to gather the additional information about effectiveness and safety needed to evaluate the overall risk/benefit relationship of the drug) is a major milestone for a biotech company. An effective regulatory compliance strategy is critical at this stage to ensure that all chemistry, manufacturing and controls (CMC) activities necessary for eventual market approval are being planned for and any identified CMC impediment is under discussion with the regulatory authorities.


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