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