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My Project|CTAP|2026-06

A reproducible mock regulatory dossier for a fictional GLP-1 / apelin (APJ) dual agonist for type 2 diabetes — 94 documents organized by ICH CTD module. For demonstration only; not medical or regulatory advice.

📖 Start with the Reader's Guide →

Module 1 — Regional & Administrative(21)

§Module 1 — Administrative Documents & Certifications Index — GLPI-103→
§US NDA — Form FDA 356h, Cover Letter & Certifications — GLPI-103→
§EU MAA — Application Form (eAF) & Cover Letter — GLPI-103→
§MFDS 품목허가신청서 & 표지서한 — GLPI-103→
§US Investigational New Drug (IND) Application — Summary — GLPI-103→
§

Module 2 — CTD Summaries & Overviews(13)

§Module 2.1 — CTD Table of Contents→
§Module 2.2 — Introduction→
§Module 2.3 — Quality Overall Summary (QOS) — GLPI-103→
§Module 2.4 — Nonclinical Overview→
§Module 2.5 — Clinical Overview→
§

Module 3 — Quality (CMC)(9)

§Module 3 — Quality (CMC) — GLPI-103→
§Module 3.2.S — Drug Substance (Full) — GLPI-103→
§Module 3.2.P — Drug Product (Full) — GLPI-103→
§Quality Target Product Profile (QTPP) & Critical Quality Attributes (CQA) — GLPI-103→
§Control Strategy — GLPI-103→
§

Module 4 — Nonclinical (Animal) Study Reports(5)

§Module 4 — Nonclinical Study Reports (Index & Stubs) — GLPI-103→
§Module 4.2.1 — Pharmacology Study Reports — GLPI-103→
§Module 4.2.2 — Pharmacokinetic Study Reports — GLPI-103→
§Module 4.2.3 — Toxicology Study Reports — GLPI-103→
§Nonclinical Data Reviewer's Guide (nSDRG) — SEND — GLPI-103→

Module 5 — Clinical Study Reports & Data(25)

§Clinical Study Protocol — GLPI103-301→
§Statistical Analysis Plan — GLPI103-301→
§Statistical Analysis Report — GLPI103-301→
§ADaM Dataset Specification — GLPI103-301→
§Tables, Listings & Figures (TLF) Shells — GLPI103-301→
§

Trial Master File — how the trial is run(10)

§Informed Consent Form (ICF) — GLPI103-301 (template)→
§Data Management Plan (DMP) — GLPI103-301→
§Clinical Monitoring Plan (CMP) — GLPI103-301→
§Data Safety Monitoring Board (DSMB) Charter — GLPI103-301→
§Randomization & IWRS Specification + UAT — GLPI103-301→

Program Management(7)

§Project Charter — GLPI-103 Development Program→
§Integrated Program Timeline & Milestones — GLPI-103→
§Clinical Program Budget & Cost Model — GLPI-103→
§Project Risk Register — GLPI-103 Development Program→
§Governance & RACI / Phase-Gate Criteria — GLPI-103→
§

Quality(4)

§Quality Management Plan (QMP) — GLPI103-301 Program→
§Protocol Deviation Log — GLPI103-301→
§Issue & CAPA Log — GLPI-103 Program→
§Decision & Action-Item Log — GLPI-103 Program→