Based on internationally recognized standards

Our guides are based on the regulations and guidelines issued by leading bodies and organizations in the pharmaceutical sector.

Why Pharmaceutical Professionals Choose Us:

  • REDUCE COSTLY ERRORS

    Translate complex regulations into clear procedures. Avoid non-compliance, findings, and penalties with practical, ready-to-use tools.

  • SAVE PRECIOUS TIME

    Editable checklists, flowcharts, and templates allow you to immediately apply the rules without rewriting procedures from scratch.

  • ALWAYS READY FOR AUDITS

    Content aligned with the latest EMA, EU GMP, ICH and GVP revisions, tested in real cases and approved in inspections.

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Key Roles in the Pharmaceutical Industry

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The Most Purchased Guides

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ICH Guidelines – Q, S, E, M: Basic Guides

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What they say about us

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  • "Finally, a guide that combines standards and practice. We used it for an EMA inspection: zero critical observations."
    Maria R. – QA Manager, CDMO in Italy

  • “The conditional release section of Annex 16 has allowed us to formalize clear and auditable procedures.”

    Thomas K. – Qualified Person , German Pharma

  • “The AIC variation templates have saved us days of work and reduced submission errors.”
    Laura P. – Regulatory Affairs Officer , UK biotech company

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Have questions? Check out our FAQs.

What are the GxP Guides?

GxP Guides are digital operational manuals for pharmaceutical industry professionals. We transform complex regulations (EMA, EU GMP, ICH, GVP) into ready-to-use checklists, templates, and procedures.

Who are they aimed at?

They are designed for several key roles: Qualified Person, QA Manager, Regulatory Affairs, Pharmacovigilance, GDP Responsible Person, Manufacturing Manager, Validation & Calibration Expert. They are useful for both those new to the industry and those with years of experience.

In what format will I receive the guides?

The guides are provided in professional PDF format, optimized for reading on PCs, tablets, and mobile devices. You'll receive them immediately after purchase.

Are they based on official regulations?

Yes. All content is based on official regulations (EMA, EU GMP, ICH, GVP, ISO) and recognized guidelines. We always include up-to-date references to ensure reliability.

Can I also use them for internal training?

Absolutely. The guides can be used as support materials for training, audit readiness, and onboarding new colleagues.

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