Pharmakovigilanz Service


To enable you to apply your resources on tomorrow's business, we provide to you our Pharma-Resources for the maintenance of your already well-established products.

Services – Pharmacovigilance GVP (Good Pharmacovigilance Practice)

Pharmacovigilance – System:

  • Compilation and reworking of a Pharmacovigilance – System
  • Compiling and accommodation of all necessary SOP´s
  • Training of staff

Literature research and corresponding signal detection

  • weekly literature research
  • research on authority websites and authority data bases
  • signal management
  • risk-benefit-evaluation
  • scientific evaluation of ICSRs and complaints
  • processing and electronic reporting of ICSRs.
  • consulting services with healthcare professionals (e.g. doctors, nurses, pharmacists) and patients.
  • Compilation of Periodic Safety Update Reports (PSUR) and Monitoring of PSUR – Deadlines
  • Compilation of Risk-Management-Plan (RMS)