Audits and Audit Programme Management

Local Knowledge, Global Coverage

Our global network of highly experienced auditors has conducted hundreds of audits throughout the world, in all of the GxPs and in a multitude of therapeutic areas. The auditing support we provide to our clients is completely scaleable and ranges from a single specialised audit to full management and execution of a company’s annual audit plan.

GxPs

  • GCP
  • GVP
  • GLP
  • GCLP
  • GMP
  • GDP
  • CSV

Audit Types

  • Investigator Sites/Facilities
  • Vendors/Suppliers
  • Process/System
  • Document

Geographical Areas

  • Europe & Middle East
  • Americas
  • Asia Pacific
  • Africa

Individual Audits

Even the largest sponsor company may not have the specialised resource needed for a specific audit, or may require additional resources during peak periods. We can support these needs with:

  • Auditors with the requisite skill set, GxP, regulatory expertise, geographical location and language skills
  • Use of either our own internal SOPs and templates or client’s SOPs, templates and platforms
  • Internal peer-review of all deliverables prior to submission to the client
  • Transparent, up-front cost estimations

Audit Programmes

We also offer set-up, management and execution of part or all of your audit programme. Audit programmes are set-up and overseen by our experienced, in-house Project Managers, who are responsible for adherence to all contractual agreements such as timelines, budget and most importantly, quality. Our Project Managers have successfully managed numerous audit programmes for small, medium-sized and large companies and can draw on a wealth of experience and best practices to ensure that your audit programme runs smoothly.

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