Vendor Management, Oversight & Audits

Vendor Management, Oversight & Audits

We ensure your vendors meet the highest quality and regulatory standards through comprehensive qualification, ongoing oversight, and audit programs. Our expertise covers supplier selection, risk assessment, quality agreements, and performance monitoring to maintain compliance with GxP, FDA, EMA, and global regulations. From initial qualification to routine and for-cause audits, we help mitigate risks and ensure seamless supply chain integrity.

We provide vendor management and oversight for CMOs, CPOs, storage and distribution providers, non-clinical labs, analytical labs, microbiology labs, bioassay labs, and CROs.

Vendor Qualification & Selection

  • Comprehensive supplier assessments and risk-based qualification
  • Development and implementation of quality agreements
  • Alignment with regulatory and industry best practices
  • Ongoing Oversight & Compliance

  • Continuous vendor performance monitoring and compliance tracking
  • Issue resolution, CAPA management, and change control oversight
  • Periodic risk assessments to ensure supply chain integrity
  • Audits & Regulatory Readiness

  • Routine and for-cause vendor audits (onsite and remote)
  • Pre-audit preparation, execution, and post-audit follow-up
  • Support for regulatory inspections and compliance assessments
  • With our structured approach, we help you build and maintain a compliant, reliable, and high-performing vendor network, ensuring supply chain integrity and regulatory excellence.