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CGMP Compliance
CGMP Compliance

Our team of professionals apply practical industry experience and scientific risk-based methodologies throughout all stages of new capital projects and in the support of existing facility operations.

Our Global CGMP compliance subject matter expertise and consulting services include:

  • CGMP compliance and QMS inspections and audits
  • Risk assessments and CGMP design reviews
  • Process mapping (application of QbD, definition of CQAs, CPPs, CMAs) 
  • CQV program development
  • Response and remediation support for regulatory observations and Warning Letters
  • Technology and manufacturing site transfers
  • Quality Management System Implementation
  • CGMP compliance training and staff development

Featured CGMP Compliance Experts

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