Regulatory Submission — FDA/EMA Dossier Structure
## Overview
Best use case
Regulatory Submission — FDA/EMA Dossier Structure is best used when you need a repeatable AI agent workflow instead of a one-off prompt.
## Overview
Teams using Regulatory Submission — FDA/EMA Dossier Structure should expect a more consistent output, faster repeated execution, less prompt rewriting.
When to use this skill
- You want a reusable workflow that can be run more than once with consistent structure.
When not to use this skill
- You only need a quick one-off answer and do not need a reusable workflow.
- You cannot install or maintain the underlying files, dependencies, or repository context.
Installation
Claude Code / Cursor / Codex
Manual Installation
- Download SKILL.md from GitHub
- Place it in
.claude/skills/regulatory-submission/SKILL.mdinside your project - Restart your AI agent — it will auto-discover the skill
How Regulatory Submission — FDA/EMA Dossier Structure Compares
| Feature / Agent | Regulatory Submission — FDA/EMA Dossier Structure | Standard Approach |
|---|---|---|
| Platform Support | Not specified | Limited / Varies |
| Context Awareness | High | Baseline |
| Installation Complexity | Unknown | N/A |
Frequently Asked Questions
What does this skill do?
## Overview
Where can I find the source code?
You can find the source code on GitHub using the link provided at the top of the page.
SKILL.md Source
# Regulatory Submission — FDA/EMA Dossier Structure ## Overview Prepare regulatory submissions for drugs, biologics, devices, and diagnostics. ## Common Submission Types ### FDA (United States) | Type | Purpose | Key Sections | |------|---------|-------------| | IND | Investigational New Drug | Chemistry, pharmacology, toxicology, clinical protocol | | NDA | New Drug Application | Full CMC, nonclinical, clinical data | | BLA | Biologics License | Manufacturing, characterization, clinical | | 510(k) | Device clearance | Substantial equivalence, performance testing | | PMA | Device approval | Clinical data, manufacturing | | EUA | Emergency use | Available data, benefit-risk | ### EMA (European Union) | Type | Purpose | |------|---------| | CTA | Clinical Trial Application | | MAA | Marketing Authorization Application | | Scientific Advice | Pre-submission guidance | ## CTD Format (Common Technical Document) ### Module 1: Administrative - Cover letters, application forms, labeling ### Module 2: Summaries - 2.1 CTD table of contents - 2.2 CTD introduction - 2.3 Quality overall summary - 2.4 Nonclinical overview - 2.5 Clinical overview - 2.6 Nonclinical written summaries - 2.7 Clinical summaries ### Module 3: Quality (CMC) - Drug substance, drug product, manufacturing, controls ### Module 4: Nonclinical - Pharmacology, pharmacokinetics, toxicology ### Module 5: Clinical - Clinical study reports, literature references ## Key Principles - Follow ICH guidelines (ICH E6 GCP, ICH Q1-Q12) - Data integrity: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) - Risk-based approach: prioritize critical quality attributes - Lifecycle management: post-approval changes and variations
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