PODCAST

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

science chemistry

All Episodes

14:28

Critical Components of a Robust CMC Due Diligence...

The VirtualPharm ·

2024/10/08

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 subst...

en-us

16:15

Building a Robust NDA/BLA Strategy: Ethan and Desi...

The VirtualPharm ·

2024/10/03

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 expectat...

en-us

10:18

A Strategic Guide to Timely Drug Approval Focused on...

The VirtualPharm ·

2024/10/01

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 submiss...

en-us

10:22

Bringing Regulatory CMC to Life

The VirtualPharm ·

2024/09/26

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

en-us

24 results

The VirtualPharm

All Episodes

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