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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.

A worker in a laboratory coat, hairnet, and face mask is handling a large quantity of chocolate-coated products in a stainless steel drum using blue gloves. The setting appears to be a sterile environment, likely a food production or quality control facility.
A worker in a laboratory coat, hairnet, and face mask is handling a large quantity of chocolate-coated products in a stainless steel drum using blue gloves. The setting appears to be a sterile environment, likely a food production or quality control facility.
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).

woman wearing yellow long-sleeved dress under white clouds and blue sky during daytime

GCP Auditing's meticulous audit of our Phase III trial was instrumental in identifying critical data integrity risks. Their recommendations significantly strengthened our TMF and EDC validation processes.

Michael Lee

A hand holding a rack containing four vials with purple caps in a well-lit corridor. The corridor has a polished floor and several fluorescent light fixtures on the ceiling. A door with a sign above it is visible in the background.
A hand holding a rack containing four vials with purple caps in a well-lit corridor. The corridor has a polished floor and several fluorescent light fixtures on the ceiling. A door with a sign above it is visible in the background.

Their expertise in ICH E6 (R3) helped us proactively update our SOPs and trial oversight. The GCP Auditing team is knowledgeable, professional, and truly understands clinical trial complexities.

Sarah Zhang

A laboratory setting featuring a conveyor belt with several test tubes placed upright in holders. The tubes are arranged in a line and have labels with barcodes. The lighting creates a cool blue tone across the surface, suggesting a sterile and clean environment.
A laboratory setting featuring a conveyor belt with several test tubes placed upright in holders. The tubes are arranged in a line and have labels with barcodes. The lighting creates a cool blue tone across the surface, suggesting a sterile and clean environment.
★★★★★
★★★★★

GCP Auditing

ASIA OFFICE

GCP AUDIT NEED

cn@gmpauditing.com

Floor 1, 281-289 Lixin Road, Fengxian District, Shanghai, China

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A sub-brand of GMP Auditing Ltd.

Expert GCP auditing services for clinical trial compliance and data integrity.

+86 180-5271-2503