Expert GCP Auditing Services You Can Trust
Qualified GCP auditors for your compliance needs.
Top auditors accepted by leading Pharmaceutical & Medical Device companies.
Broad experience in FDA & EMA regulations and compliance.
Supporting FDA & EMA regulated industries across multiple regions.
Ensuring Global Clinical Trial Compliance and Data Integrity
We provide specialized GCP auditing to ensure your clinical trials meet the highest regulatory standards, safeguarding data integrity and patient safety.
Addressing Your GCP Compliance Challenges
Trusted by Industry Leaders:
FDA Compliant
EMA Guideline Adherent
ICH E6 (R3) Focused
EDC system validation failing compliance?
Informed consent process gaps?
Delayed SAE reporting causing regulatory risks?
Expert GCP Auditing
Top-tier GCP auditing services for FDA & EMA-regulated industries with qualified GCP auditors.
Qualified GCP Auditors
Our auditors have extensive experience with FDA regulations and industry standards.
Comprehensive Audit Reports
Accepted by leading pharmaceutical and medical device companies across Europe, USA, and Japan.
We ensure compliance with FDA regulations, enhancing your operational integrity and market readiness.
Regulatory Compliance Assurance
Client Feedback
We are proud to have supported numerous organizations in achieving GCP compliance and enhancing their clinical trial quality.
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
Singapore
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
San Francisco
★★★★★
★★★★★
About GCP Auditing
Your Partner in Clinical Trial Excellence
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).
Deep expertise in ICH E6 (R3) and global GCP regulations
Team of certified GCP auditors with clinical research backgrounds
Specializing in complex multicenter and global trials
Focus on proactive risk identification and mitigation
Proven success in preparing clients for FDA/EMA inspections