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

If Data Incomplete

• Missing CTD sections → generate "[DATA REQUIRED]" placeholders with expected data sources
• ICH compliance gaps → classify critical/major/minor with remediation timeline
• Product type ambiguous → ask user to clarify drug vs. biologic vs. device

Submission Types

FDA

EMA: CTA | MAA | Scientific Advice

CTD Format

• Module 1: Administrative (cover letters, forms, labeling)
• Module 2: Summaries (quality, nonclinical, clinical overviews)
• Module 3: Quality/CMC (drug substance, product, manufacturing)
• Module 4: Nonclinical (pharmacology, PK, toxicology)
• Module 5: Clinical (study reports, literature)

Key Principles

• Follow ICH guidelines (E6 GCP, Q1-Q12)
• Data integrity: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate)
• Risk-based approach: prioritize critical quality attributes

Error Handling

• If required inputs are missing, state exactly which fields are missing and request only the minimum additional information.
• If the task goes outside the documented scope, stop instead of guessing or silently widening the assignment.
• If execution fails, report the failure point, summarize what can still be completed safely, and provide a manual fallback.
• Do not fabricate files, citations, data, search results, or execution outcomes.

Input Validation

This skill accepts requests that match the documented purpose of regulatory-submission and include enough context to complete the workflow safely.

Do not continue the workflow when the request is out of scope, missing a critical input, or would require unsupported assumptions. Instead respond:

regulatory-submission only handles its documented workflow. Please provide the missing required inputs or switch to a more suitable skill.