# Regulatory Submission

> Regulatory Submission — FDA/EMA Dossier Structure

- Skill: `biotender-max/regulatory-submission` (Agent Skill)
- Install (CLI): `npx skillmds@latest add biotender-max/regulatory-submission`
- Raw SKILL.md: https://api.skillmd.com/api/skills/biotender-max/regulatory-submission/raw
- Safety review: pending
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: Coding & Dev Tools
- Author: BioTender-max (https://skillmd.com/u/biotender-max)
- Updated: 2026-09-17
- Page: https://skillmd.com/skills/biotender-max/regulatory-submission

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# 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