Contract Development and Manufacturing Organizations (CDMOs) are often integral to the success of a pharmaceutical development program and market supply strategy.

The maturity of a CDMO’s quality systems, including supplier management, change control, and investigations handling, can mean the difference between program success or program failure. We proactively work with CDMOs to enable success. Our support includes:

• Pre-Approval Inspection Readiness
• Supplier cGMP Audits
• Qualified Person (QP) Audits
• Quality Management System Improvement
• Best-in-class CAPA and Investigations Systems
• Continuous Quality Systems Assurance (CQSA)
• Quality Agreements
• Development of CMO oversight programs, including implementation of Quality metrics