CMC for Small Molecules with PLG Expertise

The evolution of development programs for small molecules requires strong technical, documentary and strategic choices from the very first stages. In this context, ProductLife Group reinforces its position as a content leader, offering an approach that brings together regulatory vision, CMC rigour and industrial applicability. 

The webinar dedicated to CMC strategies for new small-molecule products reflects this commitment. Our specialists explain how to build a coherent, sustainable and authority-ready pathway, integrating elements of control strategy, quality, risk management and submission readiness. Thanks to PLG’s multidisciplinary expertise, teams can maintain continuity between development, manufacturing and dossier preparation, ensuring verifiable evidence and a smooth regulatory progression. 

During the session, our experts Fabio Pedna, Rania Jalal and James Crooks outline how to address the most critical steps of CMC development.
Key points include: 

• the creation of a solid control strategy from the earliest development phases 

• best practices for a consistent, CMC-focused dossier aligned across phases and regions 

• risk assessment and mitigation methods that support smoother registration 

• real-world case studies showing how integrated CMC–regulatory planning accelerates time-to-file 

The webinar is presented by Fabio Pedna and Rania Jalal, with James Crooks as moderator. 

🗓 Date: 4 december 2025 
🕒 Time: 16:00 CET 
📍 Format: Online | Free registration