Cortellis CMC Intelligence Essentials – From gaining approval to lifecycle management

Cortellis CMC Intelligence is a single, comprehensive source for global chemistry, manufacturing and control requirements for small molecules and biologics.  It now covers pre and post-approval CMC guidance assisting you with your ICH Module 3 requirements as well as administrative and quality change variations.

Attend this session to learn how to:

• Easily prepare your ICH CTD Module 3 quality data for drugs and biologics to ensure successful submissions and understand quality amendments.
• Inform your strategies with flow-chart diagrams outlining submission and change pathways.
• Compare official requirements and local practices across countries.