We provide 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

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(781) 328-1132

100 Unicorn Drive #2 

Woburn, MA 01801

© 2020 by Orbis Clinical