Regulatory Submission Compliance Architect
Architect FDA/EMA submissions with AI-powered compliance validation
What You Can Do
You can structure complex regulatory submissions with automated compliance validation, ensuring all documents align with FDA and EMA requirements. The skill validates cross-references, identifies documentation gaps, and generates audit-ready compliance evidence—reducing submission errors and accelerating approval timelines.
Features
Automatically maps your submission documents against FDA 21 CFR and EMA ICH guidelines, ensuring every requirement is addressed with clear cross-references.
Validates the logical hierarchy, naming conventions, and formatting of regulatory documents against submission standards, catching structural errors before submission.
Scans your entire submission for broken or inconsistent cross-references between documents, sections, and supporting data, ensuring complete traceability.
Generates customized compliance checklists based on submission type (510(k), BLA, IND, MAA), tracking completion status and evidence requirements.
Identifies missing documentation, inconsistencies, and compliance risks with severity prioritization to guide remediation efforts.
Provides an objective 0–100 readiness score that predicts submission success likelihood, helping you decide whether to submit or revise further.
Exports validated submissions in eCopy (FDA standard), PDF, and structured XML formats, ready for regulatory portal upload.
Example Output
Compliance Checklist Output
Product: Cardiac Monitor Model XYZ | Submission Type: 510(k) Predicate
- ✅ Device Description (Section 2.1) — Complete with images
- ✅ Intended Use Statement (Section 1.1) — Reviewed by Legal
- ⚠️ Biocompatibility Data (Section 4.3) — ISO 10993-5 pending, due 2026-09-15
- ❌ Clinical Validation (Section 5.2) — Missing 30-day follow-up data
Readiness Score: 78/100 | Estimated Gap Time: 21 days
Cross-Reference Audit Report
Missing References: 2 issues found
- Figure 2.4 referenced in Section 3.1 but not included in appendix
- Study ID REF-2025-014 cited 4 times; 1 citation missing author attestation
Inconsistencies: Device dimensions listed as 150mm (Section 2.1) vs. 152mm (Section 4.1)
Regulatory Gap Analysis
High Risk: No biocompatibility pathway selected (ISO 10993 vs. USP <87>) Medium Risk: Shelf-life validation incomplete; 6-month data submitted vs. 24-month claimed Low Risk: Device labeling font size complies with 21 CFR 801.4 but below industry best practice
What's Included
- FDA & EMA Requirement Database: Pre-built mappings of 21 CFR Part 11, Part 820, ICH Q9, and EMA guidelines, updated quarterly for regulatory changes.
- Document Structure Templates: Ready-to-use regulatory submission templates for common pathways including 510(k), BLA, IND, and Marketing Authorization Applications.
- Compliance Validation Engine: Automated checker that validates document completeness, formatting, cross-references, and regulatory alignment in real-time.
- Checklist & Audit Trail Generator: Creates compliance checklists with version control and audit evidence, inspection-ready for regulatory audits.
- Gap & Risk Analysis Tools: Identifies missing documentation, inconsistencies, and compliance risks with prioritized remediation guidance and timeline estimates.
- Quick-Start Industry Guides: Submission-type walkthroughs for pharma, medical devices, and biologics with regulatory pathway decision trees.
Who It's For
- Regulatory Affairs Managers
- Quality Assurance & Compliance Specialists
- Pharmaceutical & Biotech Program Managers
- Medical Device Regulatory Professionals
- Compliance Consultants & Contract Research Organizations
Best For
- FDA 510(k) & PMA submission preparation
- EMA Marketing Authorization Application dossier assembly
- IND/CTA regulatory submissions
- Pre-submission compliance audits & gap remediation
- Cross-functional submission documentation coordination
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