XY (Hong Kong) Medical Technology

Founded in 2019, XY Clinical Quality Oversight is dedicated to empowering global pharmaceutical, medical device, and IVD sponsors with global regulation-aligned quality solutions in Greater China.

As your trusted “authorized delegate,” we bridge the gap between global compliance standards and local regulatory realities – delivering efficiency, integrity, and peace of mind.

Core Services

• 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.

• 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.

•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.

•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.