regulatory-submission

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

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

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.