Pharmacovigilance

  • Clinical trials safety management
  • Product Safety Center (PSC) for provision of
    • Post-marketing Surveillance
    • Drug Information Services
    • Product Complaint Management
    • PSMF Preparation and Maintenance
  • Safety Database hosting with electronic regulatory reporting
  • Qualified Person for Pharmacovigilance (QPPV) in Europe
  • Global interaction with and reporting to Competent Authorities
  • Generation of CIOMS Reports
  • Aggregate periodic reporting (DSUR, PSUR, etc.)
  • Product Reporting within XEVMPD
  • Registry/ Post-marketing authorization, study design and implementation
  • Risk-Management, Crisis Management & Consulting