Expert GCP Auditing
Top-tier GCP auditing services by qualified auditors with extensive FDA & EMA & ICH regulatory expertise and experience.
Expert GCP Auditing Services
We provide top-notch GCP auditing services, supported by qualified GCP auditors with extensive experience in FDA regulations, ensuring compliance for pharmaceutical and medical device companies worldwide.
Your Compliance Partner
Trusted by Industry Leaders
Our audit reports are accepted by leading pharmaceutical and medical device companies, demonstrating our commitment to quality and compliance in FDA & EMA-regulated industries across Europe, the USA, and Japan.
GCP Auditing is dedicated to upholding the highest standards in clinical research through expert Good Clinical Practice (GCP) auditing. We partner with pharmaceutical, biotech, and medical device companies to ensure regulatory compliance, data integrity, and patient safety in clinical trials.
Our seasoned auditors leverage extensive experience and up-to-date knowledge of global regulations (FDA, EMA, ICH) to provide comprehensive and actionable insights, helping you navigate the complexities of clinical trial conduct with confidence.
We have a Local GxP Auditor Network in Asia and we have auditing partners in Europe and USA. We are committed to building the largest GxP auditor network. For local auditors, we have special advantage (Low travel costs, Local expertise and Quick Response).
GCP Auditing's meticulous audit of our Phase III trial was instrumental in identifying data integrity risks. This audit significantly strengthened our oversight capabilities over the CRO. The risk mitigation strategies identified were proactively integrated into joint quality agreements, elevating the overall reliability of clinical trial data.
Michael Lee
Their ICH E6 (R3) expertise helped us proactively update our SOPs and trial oversight. For sponsors expanding in Asia’s complex trial ecosystem, the GCP Auditing team is knowledgeable, professional, and delivers more than audit reports – they bridge global standards with on-the-ground realities.
Sarah Zhang