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Internal Safety Reports

  • ICSR/SUSAR report document (e.g. CIOMS I)
  • Single Case Assessment (if applicable)
  • PSURs (PADER)
  • Risk-Benefit-Assessment
  • Signal Detection and Review
  • EU Risk Management Plan (EU RMP)
=> Effective Support for Single Case, Safety Profile and Risk Management

We gladly support you with the required reports and the evaluation for the reporting of AEs and for the regular safety reports (line listings and review, PSURs).


Apart from this, we gladly support you with the preparation of risk-management-systems or risk-management-plans as well as the Global Pharmacovigilance Evaluation ("Signal Detection and Evaluation" as well as Risk-Benefit-Evaluation).