gabrielmoreira 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
- Identify submission type — Input: product type, development stage, market (US/EU) → Output: submission type (IND/NDA/BLA/510(k)/PMA/MAA)
- Generate CTD outline — Map to Modules 1-5 with required sections → Output: CTD table of contents
- Populate Module 2 — Draft Quality Overall Summary, Nonclinical/Clinical Overviews → Output: Module 2 drafts
- Verify data integrity — Check ALCOA+ compliance across all modules → Output: integrity audit report
- Run compliance check — Verify against ICH guidelines (E6 GCP, Q1-Q12) → ⛔ Checkpoint: Review gaps with user, prioritize remediation → Output: compliance gap list
- 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-submissiononly handles its documented workflow. Please provide the missing required inputs or switch to a more suitable skill.