CLINIQAL™ Professional Services

CLINIQAL TM, Inc. holds comprehensive commercial liability insurance for the protection of our clients!


Quality Auditing – Drugs, Biologics and Medical Device Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) audits to include:

  • Investigator Site Audits
  • Vendor Qualification Audits (e.g., Full Service CROs, Phase I Units/Clinical Pharmacology Units,  Clinical/Medical Laboratory, Electronic Systems, Drug Depots, etc.)
  • Electronic Systems Validation and Medical Software Manufacturer Audits
  • Inspection Readiness Audits (e.g., US FDA, MHRA, EMA, PMDA)
  • Sponsor Audits
  • For Cause/Directed Investigations
  • CAPA follow-up and Effectiveness Verification


  • Clinical Quality Assurance Training
  • Auditor Training
  • GCP Training (Drugs, Biologics and Medical Device)
  • Clinical/Medical Laboratory Standards Training

Clinical/Medical Laboratory Accreditation Services

  • Expert Consulting and Infrastructure development in support of ISO15189 and international College of American Pathologist (CAP) accreditations, and US CLIA (42 CFR 493) licensure.


Medical Device Good Manufacturing Practice (GMP)

  • Quality auditing
  • Training
  • Infrastructure development

Regulatory Affairs – regulatory document review, preparations and submissions

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