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regulatory-submissions

by Skills Hub

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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.

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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 skills-hub-registry-regulatory-submissions
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~/.claude/skills/<skill>/SKILL.md

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