The CMC Navigator is a structured CTD Module 3 knowledge framework that translates regulatory expectations into phase-graded requirements across Drug Substance, Drug Product, and Appendices. The full Navigator is a controlled resource; this page provides a representative preview only. For the stage-gate program model, see the interactive lifecycle map →
What the Navigator Does
The Navigator organizes Module 3 content into actionable requirements and shows how expectations mature from first-in-human development through registration. It is designed to help teams identify work earlier, expose gaps, and connect regulatory content to development execution.
Move through Drug Substance, Drug Product, Appendices, and regional requirements using the familiar Module 3 structure.
See whether an item is expected, optional, or not yet applicable at IND / Phase 1, Phase 2, Phase 3, and NDA / BLA.
Apply modality and dosage-form context so the team focuses on requirements relevant to the molecule and development path.
The public site demonstrates the architecture and value of the tool while the underlying full requirement library remains separate and controlled.
Simply hiding content with buttons, CSS, or a password written into JavaScript does not protect it: the browser still receives the data. This preview only contains the small example displayed below, so there is no complete Navigator for a scraper or AI crawler to extract from the public page.
Representative Example
A small excerpt illustrates the phase-grading logic. The complete section, regulatory-source mapping, watchouts, drafting templates, and the remainder of the Navigator are not included in the public website package.
Representative phase expectations for selected naming and identification elements.
| Representative Requirement | IND / P1 | P2 | P3 | NDA / BLA |
|---|---|---|---|---|
| Company or laboratory code name | Expected | Expected | Expected | Expected |
| Official chemical name / IUPAC / USAN | Optional | Optional | Expected | Expected |
| CAS Registry Number | Optional | Optional | Expected | Expected |
| WHO International Nonproprietary Name (INN) | N/A | Optional | Expected | Expected |
Not shown: complete line items, source citations, section watchouts, modality detail, filters, cross-navigation, and drafting templates.
Request access to the full Navigator →Full Navigator Scope
The controlled Navigator extends beyond the sample above and is organized to support practical program planning across the CMC lifecycle.
General information, manufacture, characterization, control of drug substance (specifications and analytical procedures), reference standards, container closure, and stability. 7 sections, fully phase-graded.
Description and composition, pharmaceutical development (ICH Q8(R2) QbD framework), manufacture, control of excipients, control of drug product, reference standards, container closure, and stability. 8 sections, fully phase-graded.
Facilities and equipment, adventitious agents safety evaluation (ICH Q5A, viral clearance), novel excipients, and regional content for US FDA, EU EMA, and Japan PMDA. 8 section groups, 47 subsections.
IND / Phase 1 → Phase 2 → Phase 3 → NDA / BLA views. Every requirement tagged Expected, Recommended, or As-needed at each phase.
Modality filters (Small Molecule, Cell Therapy, Gene Therapy) and dosage-form context. Section-level watchouts and regulatory-reference mapping.
Companion Excel workbook covering all Module 3 sections with a complete drafting → SME review → approval → publication workflow. Available by request alongside full Navigator access.
Controlled Access
Tell us who you are and how you intend to use the Navigator. Full access is not delivered automatically from the public website; requests are reviewed and responded to directly.
Business / professional contact information is requested to help qualify access and understand the intended use.
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