The Expertise and Support You’ve Come to Expect from Validant with Deep Roots in Europe

Validant’s established team at our regional headquarters in Cork, Ireland is comprised of leaders with more than 120 combined years of European regulatory, compliance, and quality experience. The Validant European office offers your operations in Europe the same stellar service you’ve come to expect from our consultancy, only much closer to home.

Our European team brings to bear a comprehensive understanding of EMA regulatory and compliance standards, as well as complete knowledge of the global standards that impact EU manufacturers selling in the international marketplace.

Access your EU experts.

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Tony McDonagh


  • Quality & IT consultant with 35+ years of experience in the Life Science indusrty
  • Previously Executive Director of Global IT Operations at Alexion (US & Europe)
  • Serves on the GAMP Forum in Ireland
  • Certified LIMS and SAP consultant with specialty in IT Systems Validation and 21 CFR part 11
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Kurt Moerck, Ph.D.


  • 39+ years of GMP Quality and Compliance experience
  • 30 years of global experience at 3 of the largest worldwide pharmaceutical companies; led Audit and Compliance programs for sites across the USA, Europe, LATAM, and Asia
  • Involved in nearly 100 FDA inspections over the last 7 years

A proven partner to European life science innovators.

Rapid Warning Letter Remediation for a European OTC Manufacturer

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Helping Clients of All Sizes Prepare for EU MDR/IVDR Compliance

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Coaching a Global Biopharma
to Aseptic Manufacturing Compliance

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Our world-renowned product lifecycle support—
now at your doorstep.


Define the optimal regulatory pathway.

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Streamline submissions & time to approval.

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with confidence.

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Uphold in-market product quality & integrity.

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Learn More About out End-to-End Support

Have a problem that demands local expertise?
Let’s get started.