Daudit | SERVICES
15766
page-template,page-template-full_width,page-template-full_width-php,page,page-id-15766,ajax_fade,page_not_loaded,,side_area_uncovered_from_content,qode-theme-ver-9.5,wpb-js-composer js-comp-ver-4.12,vc_responsive
 

SERVICES

Home > 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)