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GxP AUDIT SERVICES

We recognize that compliance with regulatory requirements is paramount. Therefore to support our clients, we have a full suite of Auditing and Compliance Services with the capability to perform GxP audits remotely, in-person or hybrid approaches as required by the sponsor.


TYPES OF GxP AUDITS

a. SITE AUDITS

  • Routine, targeted and for-cause

  • Inspection preparation

  • Phases I-IV

  • Mock Inspections/Pre-Inspections

b. VENDOR AUDITS

  • Site Management Organization

  • Data Management & Biostatistical services

  • Clinical Trial Supply/Distributors/Depots

  • Archival Facilities

  • Central, Bioanalytical and Specialty labs

  • Drug /Biologics/API Manufacturers

  • Other Service Providers

c. SYSTEM AUDITS

  • System/process audits

  • Clinical database audits

  • Pharmacovigilance systems


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