A Complete Guide to Regulatory Affairs in the Pharmaceutical Industry
A Complete Guide to Regulatory Affairs in the Pharmaceutical Industry
Managing Regulatory Affairs means translating complex regulations into clear, applicable procedures.
This operational guide helps you understand and practically apply the requirements for marketing authorization registration, maintenance, and variations, with a focus on ICH Q12 and the Common Technical Document (CTD).
What you’ll find inside:
📜 Simplified CTD: modular structure explained step by step
🌍 Marketing Authorization Variations (AIC): types, management, and real-world cases
✅ ICH Q12: how to implement it in product lifecycle management
🚀 Comparative tables between EU and FDA regulations
Each chapter is enriched with concrete examples, checklists, and operational boxes to streamline daily activities.
A practical manual useful both for newcomers to the field and for experienced professionals seeking to optimize processes and reduce errors.
Format: Professional PDF
Length: 102 pages
Updated: December 2025 – aligned with the latest EMA, EU GMP, and ICH revisions
Available languages: ITA – ENG
DOWNLOAD A PREVIEW OF THE GUIDE
Couldn't load pickup availability
HAVE QUESTIONS? CHECK OUT OUR FAQS
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.