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ICH Multidisciplinary Guidelines M – CTD/eCTD, Stability, Bioequivalence & Global Submissions

ICH Multidisciplinary Guidelines M – CTD/eCTD, Stability, Bioequivalence & Global Submissions

€89,00 EUR
€89,00 EUR
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The most comprehensive guide for Regulatory Affairs, CMC, QA, and anyone working with pharmaceutical dossiers.
Covers the entire CTD framework and requirements to prepare, publish and maintain an audit-ready eCTD.

Inside you will find:
📁 Operational explanation of CTD Modules 1–5 .
🌍 Global strategies for FDA, EMA, PMDA, Health Canada.
📊 Operational templates : QOS, cover letter, SOP eCTD, PLCM, checklist for each module.
⚠️ Common errors in inspection (EMA/FDA) and in the publishing phase.
🧪 Stability, bioequivalence and lifecycle management studies integrated with Q12.

Perfect for submission teams, RA specialists, CMC, QA auditors.

Format: Professional PDF
Pages: 113
Updated: December 2025
Languages: ITA – ENG

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Main references for this guide ICH M4 · ICH M7(R2) · ICH M9 · ICH M10
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