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Increased complexity in today’s regulatory environment

The increased complexity in today’s regulatory environment has led to a more conservative approach in drug manufacturing. With increased oversight come a greater number of audits. Meeting the expectations of regulatory requirements has increased pressure on drug sponsors to be more assertive and active with their CDMO. And, the pressure on the CDMO has increased as well. How do leading CDMO’s meet the challenge? Troy Carpenter, President, Vetter Pharm International USA Inc., in his interview with BioPharm TV offers his thoughts on these issues and how “straight talk with your partners” right from the start, including the identification of risk, regulatory hurdles and more, is the answer to the problem.

Describe challenges in the relationships between CMOs and drug sponsors - Meeting Regulatory Requirements and Expectation

BioPharm TV

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