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