ICH Multidisciplinary Guidelines M – CTD/eCTD, Stability, Bioequivalence & Global Submissions
ICH Multidisciplinary Guidelines M – CTD/eCTD, Stability, Bioequivalence & Global Submissions
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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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.