ServicesPharmacovigilance
Safety is crucial for patients, manufacturers and Regulatory Bodies and should be monitored throughout the product’s lifecycle.
Pharmabooks can cover Marketing Authorisations individual needs for pharmacovigilance activities and local requirements.
Safety comes first
- Local QPPV
- Local Literature Screening
- Management of ICSRs and adverse reactions
- Tailored Solutions and Services for specific activities
- Creation, overview and advice on PSMF and SDEAs
- Continuous safety profile monitoring,
- New signals detection
- Periodic Safety Update reports,
- Risk Management plans and Risk minimization activities