Drug Safety Quality Management
We will help you build comprehensive policies, processes, and procedures designed to ensure and maintain high quality processes and remain in a compliant state.

Development and management of controlled documentation (Policy/SOP/WI)

  • Design and build a PV quality function
  • Procedural document planning and development
  • Establish PV training curricula
  • Oversight of PV performance and quality metrics

Inspection readiness activities

  • Support sponsor during regulatory inspections and internal and partner PV audits
  • Create and implement inspection readiness plans
  • Provide inspection readiness training
  • Conduct mock inspections

Performance and compliance metrics

  • Help set realistic compliance and performance metrics
  • Measure and monitor compliance against metrics

Vendor and partner alliance management and oversight

  • Vendor selection and implementation
  • Vendor oversight including development of KPIs, KQls, service level agreements, and budget
  • Implementation of governance structure

Audit support

  • Audit of partners, third party vendors, and internal staff
  • Perform PV process audits
  • Build and manage PV audit annual audit calendar
We will help you gain a new perspective.
Contact us and let’s get started!
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