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.

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Service Offerings:

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• 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

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Auditing

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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