what can Compliance Audit Partners do for you?


We are a global, full service GxP Quality Assurance consulting company.

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Auditing services:

  • Investigator Site Audits
  • Vendor Audits (CRO, IVRS, EDC,   Imaging, ECG, Labs, Central IRBs, etc.)
  • Data Base Audits
  • Part 11 Audits
  • Trial Master File (TMF) Audits
  • Risk Evaluation Mitigation   Strategy (REMS) Audits
  • Pharmacovigilance (PV) Audits
  • GLP and GMP Audit Services

Regulatory Inspection preparation:

  •  Mock Regulatory Inspections 
  • Regulatory Pre-Inspection   Preparation for Sponsor, CROs, and Clinical Sites
  • Submission Document QC & QA
  • Quality Assurance Strategy   Development
  • TMF QC/QA 

Additional services:

  •  CAPA Development & Management 
  • Computer Systems Validation Services
  • Training Development and Presentation Services
  • Onsite or Remote QA Support Services