EMA/International Regulatory Submission Compliance Verifier
Verify regulatory submission readiness and identify CTD compliance gaps before EMA filing
What You Can Do
You can validate EMA and international regulatory dossiers against ICH-CTD formatting standards, identify missing documentation and compliance gaps, and assess submission readiness across all five CTD modules. Claude analyzes your dossier structure, cross-references, and critical content against regulatory requirements, then generates a detailed compliance report with prioritized remediation steps.
Features
Verify correct hierarchical organization of all five CTD modules, proper numbering schemes, and compliance with ICH formatting standards for quality, nonclinical, clinical, and summary sections.
Identify missing documentation, incomplete sections, and deviations from regulatory requirements across quality, safety, efficacy, and administrative modules with severity ratings.
Validate internal cross-references between modules, verify all cited documents are included, and ensure consistency of data across safety, efficacy, and quality sections.
Create a comprehensive submission checklist aligned with EMA guidelines, ICH-CTD requirements, and country-specific regulatory pathways to ensure nothing is overlooked.
Assess dossier maturity with risk scoring (critical, major, minor) to prioritize remediation efforts and estimate time to regulatory-ready status.
Verify document formats, metadata, file naming conventions, and submission technical requirements (PDF/A, character encoding, hyperlink functionality).
Cross-validate dossier content against your chosen regulatory pathway (centralized, decentralized, national) and identify pathway-specific documentation gaps.
Example Output
Compliance Assessment Report
Overall Readiness Score: 72% (Major Gaps Identified)
Critical Issues (Block Submission):
- Module 2.4.4 (Quality Overall Summary): Missing stability data for drug product under accelerated conditions
- Module 5 (Nonclinical Overview): Cross-reference to study XYZ123 missing from Module 2.3
Major Issues (Address Before Filing):
- Module 2.3.S.2 (Manufacture): Manufacturing process validation batches incomplete (2 of 3 required)
- Module 4.4 (Safety Update): Latest PSUR dated 18 months ago; current status unclear
Formatting Issues:
- 47 PDF files lack proper bookmarks for reviewer navigation
- 3 tables exceed 1-page width limits
Recommended Timeline to Submission-Ready:
- Priority 1 (Critical): 4-6 weeks
- Priority 2 (Major): 8-10 weeks
- Priority 3 (Minor): 2-3 weeks
Next Steps: Generate detailed remediation plan for Quality module; coordinate with clinical team on PSUR update.
What's Included
- Dossier Structure Assessment: Complete validation of CTD hierarchical structure, module completeness, and conformance to ICH M4 formatting standards.
- Compliance Gap Report: Detailed identification of missing documentation, incomplete sections, and regulatory requirement deviations with severity levels and remediation guidance.
- Risk-Based Readiness Score: Quantified assessment of submission maturity across critical, major, and minor issues with prioritized action list.
- Regulatory Checklist: Comprehensive document and content checklist aligned with EMA guidelines, ICH-CTD, and pathway-specific requirements.
- Cross-Reference Validation Report: Verification of all internal cross-references, external document citations, and data consistency across modules.
Who It's For
- Regulatory Affairs Managers
- Quality Assurance/Compliance Officers
- Clinical Development Leads
- Pharmaceutical Project Managers
Best For
- Pre-submission dossier readiness assessment
- CTD formatting and structure validation
- EMA submission preparation and compliance verification
- International regulatory pathway alignment checks
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