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Professional Services

Quality Auditing


Project Management

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

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