The VirtualPharm

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.

Support the show

Welcome to "Accelerating the Path to Approval", hosted by Ethan and Despina from Enkrisi. In this podcast, we explore the critical steps in developing a robust Regulatory Chemistry, Manufacturing, and Controls (CMC) strategy that can make or break a successful New Drug Application (NDA) or Biologics License Application (BLA) submission.  

Today, we’ll be diving into the 5 Strategic Steps that ensure your CMC foundation is strong, well-structured, and aligned with regulatory expectations, significantly enhancing your chances of approval. From early regulatory engagement to continuous risk mitigation, we’ll walk you through real-world examples and case studies that illustrate the key elements in preparing a successful submission.  

Ethan and Despina will also explore how early alignment with FDA and ICH guidelines, along with a transparent, data-driven approach, can streamline your approval process. Whether you're navigating the complexities of small molecules, biologics, or combination products, this podcast is your guide to mastering the regulatory landscape and accelerating your path to market. 

Support the show

 In this insightful episode, hosts Ethan and Desi take you on a deep dive into the drug approval process, emphasizing the critical role of Chemistry, Manufacturing, and Controls (CMC) documentation. With a focus on what sponsors often miss, the discussion highlights how inadequate preparation in key areas like stability studies, process validation, and facility readiness can lead to costly delays or rejections. The episode is packed with actionable advice on how to streamline the submission process, collaborate effectively with Contract Manufacturing Organizations (CMOs), and ensure regulatory compliance to expedite drug approval. Whether you're navigating the NDA or BLA submission process, this episode provides a strategic roadmap to success in drug approvals. 

Support the show

We are excited to announce the launch of our brand-new podcast, The VirtualPharm: The Regulatory Intelligence Podcast—where we bring Regulatory CMC to life! 🎉

Hosted by industry veterans with decades of experience, The VirtualPharm dives deep into the most pressing and complex topics in Chemistry, Manufacturing, and Controls (CMC). Whether you're navigating the latest FDA regulations, preparing submissions, or tackling intricate compliance challenges, this podcast is your go-to resource for actionable insights and expert guidance.

Why Listen?

• In-Depth Episodes: Explore the latest trends, challenges, and strategies in Regulatory CMC.
• Expert Hosts: Learn from seasoned professionals driving innovation in the biotech and pharmaceutical industries.
• Real-World Solutions: Gain practical advice to help you stay compliant and agile in today’s fast-paced regulatory environment.

Support the show