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

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Global Auditing Services:

Globally based consultants provide:

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
Onsite Inspection Support
Submission Document QC & QA
Quality Assurance Strategy Development
TMF QC/QA

Document Audits/Quality Control:

Study Documents (Clinical Study Reports, Tables, Listings and Figures, Protocol, Investigator Brochure, Informed Consent Forms, etc.)
Submission Documents (FDA/EMA)
Trial Master File

Additional Services:

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