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