PHARMACOVIGILANCE SERVICES

  • The services provided by Asgenia ensure the complete management of your pharmacovigilance system, in accordance with the regulations. Additionally, we can offer individual aspects of the system to address specific requests and needs of the company.
  • PV System Management
    • PSMF
    • SDEA
    • Database Art.57 – XEVMPD
    • ICSRs & SUSARs Reporting
  • Case Management
    • ICSRs Collection
    • Literature Screening
    • PV Databacklog
  • QPPV/Deputy QPPV Local Contact Person
    • 7/7 - H24 Availability
    • Overview of PV and QA System
  • Medical Services
    • Medical Evaluation
    • Medical Information
    • Medical Writing
  • Periodic Safety Reports
    • Signal Detection
    • Regulatory Intelligence
    • ACO, PSUR, DSUR
    • Risk Management System
  • PV & QA Consultancy
    • PV Quality System Management
    • PV & QA Training Center
    • Medical Support
    • PV Company Backup
    • PV & QA Personnel Outsourcing
    • Supply of PV Database
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