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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 labs / Bioanalytical labs​
  • GLP – Testing / Analytical​
  • GVP – Affiliates / QPPV / LSO​
  • GMP – CMO Qualification​
  • Biostatistics / Data Management

Audit Locations

  • USA (12 states)​
  • Canada​
  • China​
  • Singapore​
  • France ​
  • UK​
  • Belgium ​
  • Hungary ​
  • Germany​
  • Sweden​
  • Australia​
  • South Korea​
  • Ireland​
  • Poland ​
  • Romania​
Frame 1000005946

Scope of work

Done

Solely responsible for conducting our client’s full yearly audit program​;

Done

Audits range across GxP, covering 15 countries and 12 USA states​;

Done

Conduct of the audit, initial meeting, interviews with key members of the site, review of documentation & exit meeting​; 

Done

42 audits across 2023;​

Done

Apotech Auditors liaising directly with vendors and sites to arrange dates and pre-audit meetings;

Done

Audit report after 21 days and issue of Audit Certificate​;

Done

Involved in planning the clients audit schedule for the following year.

Have a project in mind_ Let’s work together!
Client quote

Apotech delivered a responsive and high standard of service, delivering in each of the site locations as per request. From start to finish the process was smooth and without any notable issues.

Key numbers

Management

Team

23 auditors

Charity

Location

Worldwide

Combo Chart

Length

2 Year Contract

WeChat

Type

Full Service Provision

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Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.