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.
Routine, targeted and for-cause
Inspection preparation
Phases I-IV
Mock Inspections/Pre-Inspections
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
System/process audits
Clinical database audits
Pharmacovigilance systems
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