Individual skill

regulatory-submission

Prepare FDA/EMA regulatory submissions (IND/NDA/BLA/510(k)/PMA/MAA) in CTD format. Generate module outlines (Modules 1-5), run ICH compliance checks (ALCOA+, E6 GCP, Q1-Q12), verify data integrity, and produce submission-ready dossiers with cover letters and checklists.

scientific-skills/Academic Writing/regulatory-submission/SKILL.md

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Repository stars (not skill ratings): 2,042
Repository last updated: Sep 17, 2026
License: MIT

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> **Source**: [https://github.com/aipoch/medical-research-skills](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