Pharmacovigilance
Focus: providing a high-quality, customised solution.
Our services include:
Safety Management Strategies – Developing project specific Safety Management Plans for drugs, and devices and strategy for inspection readiness.
Safety Database Hosting – Cost effective, EU-based database system providing regulatory and GDPR compliant case processing and report generation.
Individual Case Safety Reports (ICSR) Processing – European-based case processing by HC professionals with an average of 10- years of pharmacovigilance experience focused on:
- Quality
- Follow-up due diligence
- Timely distribution to authorities and partners
Regulatory Reporting – Monitoring of Safety Regulatory Intelligence ensuring timely reporting of ICSRs and aggregate reports (DSUR, PSUR, PBRER) to regulatory and competent authorities.
Signal Detection and Assessment – Review of individual ICSRs, line listings, aggregate and signal reports to proactively identify trends and signals.