Watch Now: M4Q(R2) – The Road to Pragmatic, Modernized CMC Submissions

The ICH M4Q guideline is undergoing its first major revision in more than two decades, reshaping how pharmaceutical companies will organize, justify, and maintain quality information across the product lifecycle. As global expectations rise and regulatory scrutiny intensifies, understanding M4Q(R2) is essential for teams responsible for CMC documentation and submission strategy.

In this on-demand webinar, our expert breaks down the proposed updates in M4Q(R2) and explains how new elements such as Core Quality Information (CQI), Development Summary & Justification (DSJ), and Product Lifecycle Management (PLCM) will influence current and future submissions. Learn what is changing, why it matters, and how this modernization supports more structured, consistent, and efficient regulatory filings.

Why Watch

If your teams support CMC authoring, quality documentation, or lifecycle management, this session will help you understand how the revised M4Q framework may impact your processes, timelines, and submission readiness. The webinar outlines where the industry is heading and offers clarity on how organizations can prepare for a shift toward more structured and lifecycle-driven CMC information.

Watch the webinar recording now and gain insight into adapting your CMC documentation strategy for a modernized regulatory environment.