Conducting and Supporting GxP Audits

Regulatory inspections depend on the quality of your systems, your oversight, and your documentation. Independent audit visibility is essential to understanding where you stand.

I perform GxP audits across clinical and quality domains, including GCP, GLP, and GVP, providing a clear, objective assessment of compliance and operational risk.

Audits are tailored to your organization’s stage of development, risk profile, and regulatory obligations, with a focus on delivering practical, actionable findings.

This includes:

• Qualification and routine audits of CROs and vendors

• Internal audits of quality systems and processes

• Inspection readiness assessments and mock inspections

• Gap analyses aligned to applicable regulatory requirements and guidance

• Support with audit responses, CAPA development, and remediation planning

All audits are conducted independently and delivered directly by a senior GxP auditor, with a practical, risk-based focus on what matters most during regulatory inspection.