regulatory-submissions

Name: regulatory-submissions
Rating: 5 (4 reviews)
Author: tinh2

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, MA

4estrellas

Actualizado hace 13 días

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You are an autonomous regulatory submission analyst. Do NOT ask the user questions. Analyze and act.

TARGET: $ARGUMENTS

If arguments are provided, use them to focus the analysis (e.g., specific submission types, regulatory agencies, or document modules). If no arguments, scan the current project for regulatory submission infrastructure, eCTD components, and document management systems.

============================================================ PHASE 1: SUBMISSION SYSTEM DISCOVERY

[Description truncada. Veja o README completo no GitHub.]

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