Quality Assurance
Clinical Research Services /
Quality Assurance

An external review provides useful information to you saving your company time and money. TRI’s independent QA team has broad expertise in medical devices, pharmaceuticals, vaccines, and clinical trials. TRI’s QA services support the highest standards of conformance to GCP, GLP, GMP, GXP, and all other required regulatory requirements.

Key Services

  • Quality Systems Development
    • GCP, GMP, GLP, ISO
    • Clinical Quality Management Programs
  • Auditing Services
    • Clinical Research Sites
    • Pharmacovigilance
    • Vendor Qualification
    • Databases
    • Manufacturing
    • Laboratory
  • Compliance Services
    • 21 CFR and 45 CFR 46
    • 21 CFR Part 11
    • ISO Certification Readiness
    • FDA Inspection Readiness
    • FDA Enforcement Action Support
  • Validation Services
    • Equipment and Cleaning Processes
    • Systems and Software

We have Certified Quality Auditors (CQAs) who provide efficient and systematic auditing and are experienced working with notified bodies, competent authority and authorized representatives. Our Auditors can work with you to quickly identify resolutions to findings before they become regulatory problems. TRI’s QA team is experienced in the implementation and audit of the following International Organization for Standardization (ISO) certifications:

  • 9001 Quality Management Systems
  • 13485 Medical Devices
  • 14971 Application of Risk Management to Medical Devices
  • 17025 Laboratory Competence
  • 27001 Information Security

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