QbD & PAT: Achieving Regulatory Approval of Processes
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Dr. Sushil K. Srivastava is the Director of Chemical Development (Drug Substance), Pharmaceutical Development at Bristol-Myers Squibb (BMS). He is responsible for late phase development including QbD/PAT, technology transfer of drug substance processes to commercial manufacturing sites and providing source documents for CMC filings and responses to Health Authority questions. In this exclusive Pharma IQ interview, he shares his perspective on regulation, compliance and integration, ahead of th...
