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SERVICES

AUDITING

  • Pre and post-marketing full system Good Pharmacovigilance Practice (GVP) audits
  • Strategic and tactical audit programmes and risk assessment
  • Tailored GVP process audits
  • Pharmacovigilance vendor and partner audits
  • GVP inspection readiness
  • Good Clinical Practice (GCP) Audits on investigational sites, Clinical Research Organisations (CROs) and vendors

CONSULTING

  • Quality Management Systems
  • Quality Objectives
  • Standard Operating Procedure (SOP) development
  • GVP gap analysis
  • Compliance and Key Performance Indicators (KPIs)
  • Post audit/inspection Corrective and Preventive Action (CAPA) formulation and response
  • Pharmacovigilance training
  • Pharmacovigilance System Master File (PSMF)
  • Safety Data Exchange Agreements (SDEA)