Quality Assurance

Integrates day-to-day GxP operations to support all stages of drug development.

Core Competencies:

  • Quality Document
    • SOPs, documents systems
  • Quality Assurance
    • Document review, drug release, audits
  • Quality Control
    • In process controls, validation
  • Quality Issue Management
    • Investigations, deviations, OOS, CAPAS

Commonly Requested Services:

  • Prepare/revise corporate SOPs appropriate to the stage of product development
  • Conduct GxP audits
  • Establish Quality Agreements Provide QA review/approval of master/executed batch records, specifications, test methods, validation and stability protocols and reports
  • QA release of products materials
  • PAI readiness training
  • Mock audits

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