Chemistry, Manufacturing and Controls spans every CTD Module 3 section from Drug Substance through Drug Product to Appendices. Understanding what is required at each phase is the foundation of a well-governed development program.
Preview CMC Navigator →View Development TimelinesThe Three CMC Areas
Every NDA and BLA requires a complete CTD Module 3 package. CMC Drug Development maps what is required in each section, by phase, modality, and dosage form — so development teams know what is needed before it is due.
General Information, Manufacture, Characterisation, Control of Drug Substance, Reference Standards, Container Closure, and Stability. Sections 3.2.S.1 through 3.2.S.7 — every requirement mapped by phase.
Description and Composition, Pharmaceutical Development, Manufacture, Control of Excipients, Control of Drug Product, Reference Standards, Container Closure, and Stability. From formulation development through commercial readiness.
Facilities and Equipment (3.2.A.1), Adventitious Agents Safety Evaluation (3.2.A.2 — ICH Q5A, viral clearance, cell banking), Novel Excipients (3.2.A.3), and Regional content for US FDA, EU EMA, and Japan PMDA. 8 section groups, 47 subsections.
Phase-Graded Expectations
IND, Phase 2, Phase 3, and NDA/BLA each carry different CMC expectations. The Navigator tags every requirement as Expected, Recommended, or As-needed at each phase — so teams can plan the right work at the right time.
Safety-focused package. Enough characterisation to support first-in-human dosing. Process and controls at a scale sufficient for clinical trial material manufacture.
Progressively more complete. Commercial process begins to emerge. Stability data accumulates. Analytical methods are validated. Control strategy is formalized.
Complete, validated package. Commercial manufacturing process qualified. Long-term stability supporting proposed shelf life. Full analytical validation across all methods.
The interactive stage-gate model on the homepage maps every development phase — Discovery through Commercial — with deliverable counts, task counts, estimated costs, gate milestones, and SME approver requirements across Small Molecule, Cell Therapy, and Gene Therapy. Click any phase or gate to explore.
Ready to Navigate?
The CMC Navigator demonstrates phase-graded CTD requirements across 3.2.S, 3.2.P, and 3.2.A. The CMC Regulatory Filing Tracker provides a ready-to-use spreadsheet for managing the drafting, review, approval, and publication workflow across all Module 3 sections.