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Post-Approval
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Good Clinical Practice (GCP)
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Inspection Readiness
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Achieving Market Access
Organizational Assessment, Strategy and Design
Implementation, Excellence and Transformation
M&A Regulatory Due Diligence and Integration
Digital Technology Advisory
Functional Outsourcing Staff Augmentation Regulatory & Market Access Strategy Advisory & Strategic Consulting
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  • Pre-Approval
  • Authoring, Publishing and Submissions
  • Post-Approval
  • Special Projects
  • Go back
  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Inspection Readiness
  • Go back
  • Strategy Development
  • Achieving Market Access
  • Go back
  • Organizational Assessment, Strategy and Design
  • Implementation, Excellence and Transformation
  • M&A Regulatory Due Diligence and Integration
  • Digital Technology Advisory
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    Meet the Team
    Paul Kuiken

    Paul Kuiken

    Vice President, Advisory Practice

    Biography

    Over the last three decades, Paul has worked across a broad range of disciplines including process engineering, quality assurance, regulatory affairs, business development and commercial operations management.

    A member of TOPRA for over 20 years, he has enjoyed a number of voluntary roles with the body including editorial board member for Regulatory Rapporteur, working in the MSc Regulatory Affairs Module 9 Working Party and as a Biotech SPIN member.

    Paul completed his Global Executive MBA at the prestigious Henley Business School in 2023.