The VirtualPharm
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
The VirtualPharm
Critical Components of a Robust CMC Due Diligence Framework (with a Focus on Drug Substance)
Podcast Description:
In this episode, we explore the essential components of a robust Chemistry, Manufacturing, and Controls (CMC) due diligence framework, with a special focus on drug substance evaluation. Join us as we break down the comprehensive steps involved in conducting due diligence during pharmaceutical acquisitions or in-licensing. From regulatory compliance to technical assessments, we discuss how to mitigate risks, enhance regulatory readiness, and ensure the quality of drug substances. This episode highlights the importance of aligning CMC due diligence with international guidelines, like the ICH’s CTD Module 3, and emphasizes the role of multidisciplinary teams in navigating the complexities of drug development. Whether you’re a regulatory professional or working in pharmaceutical development, this discussion provides key insights for a successful CMC due diligence process.