Source: https://github.com/aipoch/medical-research-skills

Regulatory Submission — FDA/EMA Dossier Structure

When to Use

• Preparing FDA/EMA regulatory submissions (IND/NDA/BLA/510(k)/PMA/MAA)
• The user mentions regulatory submission, FDA, EMA, IND, NDA, BLA, CTD, dossier, or regulatory affairs
• Generating CTD module outlines and compliance checks for dossier assembly

Workflow

1. Identify submission type — Input: product type, development stage, market (US/EU) → Output: submission type (IND/NDA/BLA/510(k)/PMA/MAA)
2. Generate CTD outline — Map to Modules 1-5 with required sections → Output: CTD table of contents
3. Populate Module 2 — Draft Quality Overall Summary, Nonclinical/Clinical Overviews → Output: Module 2 drafts
4. Verify data integrity — Check ALCOA+ compliance across all modules → Output: integrity audit report
5. Run compliance check — Verify against ICH guidelines (E6 GCP, Q1-Q12) → ⛔ Checkpoint: Review gaps with user, prioritize remediation → Output: compliance gap list
6. Finalize dossier — Compile modules, generate cover letters, verify cross-references → Output: submission-ready package