CTD Regulatory Library
Complete reference for Common Technical Document requirements. Every section includes phase-specific requirements (IND Phase 1–3, NDA) based on ICH M4Q, M4S, and M4E guidelines.
218
CTD Sections
5
Modules
4
Phase Levels
46
ICH Guidelines
Administrative Information
55FDA Form 1571Investigator's BrochureFinancial Disclosure
CTD Summaries
24Quality Overall SummaryClinical OverviewNonclinical Summaries
Quality (CMC)
703.2.S Drug Substance3.2.P Drug ProductStability Data
Nonclinical Study Reports
36Safety PharmacologyRepeat-Dose ToxicityGenotoxicity
Clinical Study Reports
28Phase 1 PK StudiesPivotal Efficacy TrialsSafety Summary
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Start Compliance CheckBased on ICH M4(R4), M4Q(R1), M4S(R2), M4E(R2) and 21 CFR 312.23