Quality auditing services supporting Pharmaceutical, Biotechnology, and Medical Device Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Human Sample Bioanalyltical analysis (i.e., GCLP non-clinical/medical lab) and Clinical/ Medical Laboratory audits to include:

• Clinical Quality Assurance (CQA) Infrastructre Develompment, Implementation and Management Services

• Investigator Site Audits

• Vendor Qualification Audits (e.g., Full Service CROs, Phase I Units/Clinical Pharmacology Units, Clinical/Medical Laboratory/Central Laboratory, Electronic Systems, Drug Depots, etc.)

• GMP audits of Class II Significant Risk and Class III Medical Device, and Pharmaceutical and Biologic Manufacturers 

• Electronic Systems Validation and Medical Software Manufacturer Audits

• Inspection Readiness Servcies/ Mock Regulatory Inspections (e.g., US FDA, MHRA, EMA, PMDA) 

• For Cause/Directed Investigations

• CAPA follow-up and Effectiveness Verification