AnalysisOfficial
regulatory-submissions
Audit a pharmaceutical regulatory submission system -- evaluate eCTD backbone assembly and XML validation, CTD module completeness (Modules 1-5), FDA ESG and EMA CESP gateway integration, document authoring and publishing workflows, ICH M4/M8/E3 guideline compliance, pre-submission validation rules, 21 CFR Part 11 audit trails, and post-submission lifecycle tracking. Covers IND, NDA, BLA, ANDA, MAA, and variation submissions using Veeva Vault RIM, IQVIA, Lorenz docuBridge, or custom platforms.
v2.0.0New
Signing
SignedSLSA L2- Signed by
- skills-hub.ai distributor
- Method
- Distributor-signed by skills-hub.aiCryptographically signed by the skills-hub.ai distributor key at publish time.
- Signed
Install this skill
Run this command in your terminal. No account required — it auto-detects your AI tool and installs the skill file.
npx @skills-hub-ai/cli install regulatory-submissionsOr download directly:
Browse all CLI commands →Setup by platform
Install
One-click setup for your editorRun in your project root
npx @skills-hub-ai/cli install regulatory-submissions --target claude-codeInstructions
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