A Practical Guide To Writing Robust Chemistry, Manufacturing, And Controls Dossier Modules To Support First-In-Human Trials

Getting CMC documentation right for a first-in-human submission means knowing what regulators expect at this stage, and where the emphasis should fall.

This infographic organizes the key considerations across the CTD's CMC modules into a practical checklist, covering characterization of critical quality attributes, health and safety dimensions of manufacturing and process controls, reference standards, drug product development, and stability data requirements. Two principles run throughout: follow published guidelines rather than improvising, and keep patient safety considerations visible across the document.
 

The checklist also addresses planning realities, including how to identify gaps and manage updates as development details evolve. For teams preparing their first IND or IMPD, it offers a structured reference for drafting documentation that is both phase-appropriate and reviewer-ready.

Explore the full infographic to sharpen your approach to FIH CMC submissions.