™, LLC provides domestic and global Quality Assurance (QA) services for the Pharma, Biotech, and medical devices industries.

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Audit experience includes 250+ audits (195 as lead) of all stages of clinical trials (Phase I-IV) for compliance with FDA, ICH, MHRA, EMA, and national GCP guidelines / regulations in a variety
of therapeutic areas in 26 different countries throughout North, Central and South America, Europe, Israel, Japan, New Zealand, and Australia.

Expertise in Clinical Auditing, System Audits, Pharmaceutical Quality Systems (, CAPA management, ICH-GCP compliance (, QMS gap analysis, Third Party audits, GCP auditing, Clinical Quality Assurance (CQA), Contract Audit Services, Due Diligence audits, QA training and Quality Risk Management (
Extensive experience in leading complex, domestic and international system audits covering all aspects of the clinical research business including:

- Clinical Quality Assurance (QA)
- Support & development of Good Clinical Practice (GCP) Programs
- Investigator site audits
- Clinical documents review
- Trial Master File
- FDA Pre-Approval Inspection (PAI) readiness
- FDA and local health authority inspections
- Vendor qualification audits
- Institutional Review Board (IRB)
- Distribution providers
- Contract Research Organization (CRO)
- Central and Local Laboratories
- GxP compliance support
- Pharmaceutical Quality Systems (PQS)
- Pharmacovigilance compliance
- Clinical Pharmacology Unit (CPU)
- Quality Management Systems (QMS)
- Site Management Organization (SMO)