Orbis Clinical has the quality assurance expertise to assist life sciences organizations with their highly regulated products. Our consultants provide world-class quality support across all facets of research and development, from pre-clinical to post-market.

Service Offerings:

  • Quality Assurance, Quality Control and Quality Systems Subject Matter Expertise
  • Remediation
  • Site Readiness Assurance
  • Batch Record Review
  • Document Control
  • ISO Compliance
  • CAPAs and Quality Management Plans
  • FDA 483 Response Preparation and Review
  • SOP Development and Review
  • Policy Development, Validation Guidelines, Validation Plans, Test Plans and Procedures
  • Project Management

 Auditing

  • Internal and external, domestic and international GxP auditing of:
  • GMP
    - Manufacturing Facilities (API, Drug Product, Sterile Product)
    - Manufacturing (Excipient/ Raw Material)
    - Analytical Lab (Micro, Stability, Release)
    - Clinical Packaging/Distribution
  • GCP / GLP / GCLP / GVP
    - CROs, Investigators, Monitors, Suppliers & Study Sites
    - Contract, QC, Central, Specialty & Analytical Laboratories
    - Safety Reporting / PV Audits / Software Vendor
  • Licensing Partners & Agreements

To learn more about our services, contact us today!