Cortellis CMC Intelligence essentials

Cortellis CMC Intelligence is a single, comprehensive source for global chemistry, manufacturing, and control requirements for small molecules and biologics. This easy-to-use tool provides the latest, up-to-date pre-marketing CMC requirements focusing on the ICH’s CTD Module 3 quality data, helping you plan and prepare your drug submissions successfully.

Join this session to learn how this tool can help you:

  • Find the official requirements and local practices needed to prepare the quality section of a submission dossier
  • Understand regulatory authorities’ requirements for manufacturing, quality validation plus specifications and test procedures
  • Compare requirements across countries and regions
  • Never miss a new requirement by setting up email alert notifications

Details
  • Date:
    September 14, 2022
  • Start Time:
    10:00 am EST
  • End Time:
    11:00 am EST
  • Share: