Pharmacovigilance-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)