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Good Clinical Practice (GCP) Audit Services

Identify compliance issues and ensure regulatory alignment with comprehensive GCP audits from SGS.

GCP ensures the ethical and scientific quality of clinical trials. In a landscape marked by stringent regulatory requirements, organizations face the challenge of maintaining compliance while efficiently managing resources.

We provide risk-based GCP compliance audits for Phase I-III clinical trials, pinpointing potential non-compliance areas to ensure strict adherence to regulations and save organizational resources. 

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A comprehensive range of GCP audit services

We provide a wide range of GCP audits, covering study audits and qualification audits, including:

  • Trial master file audits
  • Investigator site audits
  • Phase I unit audits
  • Vendor audits

Ensure your trials proceed seamlessly – in full compliance

We enable you to:

  • Receive an impartial, independent audit:

    for an objective evaluation of your organization's risk and compliance

  • Ensure regulatory alignment:

    avoid penalties and legal consequences

  • Identify potential issues early:

    implement corrective actions and preventive measures

  • Gain peace of mind:

    our comprehensive audits cover all your needs

  • Leverage extensive GXP expertise:

    benefit from our primary expertise in GCP along with experience in other GXP, including GCLP, GMP, and GAMP 5

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Trusted GCP compliance from a world-leading auditor

As the global benchmark for quality and integrity, we offer a hands-on, straightforward approach to GCP compliance audits. Our extensive operational and audit experience, and broad network of subject matter experts ensure a comprehensive audit process, tailored to the specific needs of your clinical trials.

Our experienced audit team offers broad European coverage, conducting thorough audits across study phases. With a focus on GCP regulations – our team excels in qualifying and evaluating compliance for both sites and vendors. 

Ready to meet the highest standards of GCP compliance?
Contact us today to learn how our experienced auditors can support your journey towards regulatory alignment and operational excellence.

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  • SGS Korea Co., Ltd.

12FL, Chongryong Bldg., 257, Hangang-daero, Yongsan-gu,

, 04322,

Seoul, Korea, Republic of