Compliance Audit Partners LLC

Compliance Audit Partners (CAP) LLC. A full service, global GxP Quality Assurance consulting company That offers services in the following areas: Audit 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 Standard Operating Procedures • Process Gap Analysis • Process Mapping • SOP Development CAPA Development & Management Computer Systems Validation Services Training Development and Presentation Services Onsite or Remote QA Support Services