GCP/GCLP Audits

Independent, thorough audits for sites, CROs, and vendors. Our audits cover protocol adherence, data integrity, consent processes, and facility compliance – with deliverables including detailed audit reports, risk ratings, and follow-up support to address findings.

Inspection Readiness & CAPA Support

Prepare for NMPA or global regulatory inspections with confidence. We conduct mock inspections, organize documentation (eCRFs, TMFs), and support corrective and preventive action (CAPA) implementation – ensuring you’re audit-ready at all times.

Quality Assurance & Gap Assessments

Identify compliance gaps before they become risks. Our team conducts comprehensive assessments of your existing processes, compares them to Global Regulation and NMPA standards, and provides a prioritized action plan to strengthen your quality system.

CRO/Investigator Performance Oversight

Our oversight directly addresses Global Regulation’s enhanced sponsor responsibilities. We conduct targeted monitoring, assess performance against protocols and SOPs, and deliver actionable reports to drive improvements. As your authorized delegate, we ensure accountability at every stage – from site initiation to study closeout.