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Cortellis CMC Intelligence Essentials – From gaining approval to lifecycle management (45 min incl Q&A)

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.