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A Complete Guide to Regulatory Affairs in the Pharmaceutical Industry

A Complete Guide to Regulatory Affairs in the Pharmaceutical Industry

€149,00 EUR
€149,00 EUR
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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

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DECLARED REGULATORY BASIS

Built on the most up-to-date official sources.

Every guide is built from the official sources current at the editorial verification date stated in the document. The editions, revisions and cut-off dates used are declared and checked again for every new release; requirements are kept distinct from GuideGxP operational interpretation.

Main references for this guide EudraLex · EMA procedural guidance · ICH CTD/eCTD
  • Editions and revisions stated in the document
  • Explicit editorial verification date
  • Requirements separated from practical recommendations

GuideGxP is an independent publisher and is not affiliated with, approved by or sponsored by the authorities and organisations cited.

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Every new release is delivered automatically by email.

Buy once: whenever we publish a new release of the guide you purchased, it is sent automatically to the email address used for the order, together with the download link. No request, new registration or additional payment is required.

  • Every future release included for life
  • Automatic delivery to the order email
  • Average review cycle: 6 months

Timing may vary with regulatory and technical developments. No action is required after purchase; simply use a valid email address at checkout.

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