Good Clinical Practice (GCP) Audit
We maintain a thorough awareness of the latest Good Clinical Practice (GCP) requirements to ensure compliance. Our team possesses the necessary expertise to assess whether other organisations adhere to GCP standards.
GCP audits are an essential component of the quality assurance system in clinical trials for both medicinal products and medical devices. But, if your resources are limited, we can help.
With audits able to be conducted either remotely or on-site, our team at Apotech boasts a qualified team of GCP auditors that can independently assess any Contract Research Organisations (CROs) pre-selected to conduct clinical trials or evaluate ongoing trials.
Trusted by top-tier teams worldwide
Our Good Clinical Practice auditing services cover:
- Investigator sites
- Clinical Research Organisation (CRO)
- Vendors
- Mock Inspections
- Documentation
- Trial Master File (TMF)
- Systems and internal processes
- Data Management
- Statistics and programming
Our Global Reach
We take pride in our extensive global audit network and are committed to utilising local auditors based in-country.
This approach offers several key benefits: local auditors possess in-depth knowledge of regional regulations, communicate effectively in the local language, and help reduce travel expenses for our clients. We have successfully provided support in all the regions highlighted on the map below.
FAQs on Audits
We provide a modern approach to auditing that offers full transparency. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, our team can provide comprehensive CAPA (Corrective and Preventive Action) Management support.
Our modern and flexible approach ensures effective handling of CAPA processes, helping not only address and prevent any non-conformities but also contribute towards the continual improvement of both quality and compliance.
Featured case studies
GCP Audits – Europe
Seagen is a global biotechnology company dedicated to revolutionizing cancer care. They are Headquartered in the US & Switzerland with a large footprint in the EU.
GxP Audits – Worldwide
GxP Audits – Worldwide Introduction Global Biopharmaceutical Our client is a global biotechnology company dedicated to novel treatments for patients through inhibition of protein kinases to fight cancer. They are Headquartered in the US, with a large footprint in the EU. Types of Audits GCP – For Cause / Investigator / Phase 1 unit GCLP – Central…
GCP Mock inspections – Europe
GCP Mock inspections Europe Introduction Danish R&D Pharmaceutical Company Our client is a pharmaceutical company committed to ensuring compliance with global regulatory standards, particularly FDA requirements for clinical trials Apotech auditors Our Auditors have 20+ years’ experience, all based locally with extensive experience in FDA inspections and GCP compliance. Collectively conducted over 50 regulatory inspections…