ICSR Case Processing

Triage
Data entry
Med DRA Coding
Narrative writing
Medical review
Quality Control
Medical review
Submission

Aggregate Safety Reports

Periodic safety updated Reports (PSUR)
Periodic benefit risk evaluation report (PBRER)
Development safety update report (DSUR)
Periodic Adverse Drug Experience Report (PADER)
Annual Reports

Risk Management Plan

Navatio Pharma provides strategic advice and analysis; develops US for risk evaluation and mitigation strategies (REMS)
REMS update reports
Risk management plans (RMPs) for Europe

Signal Detection

Identified and potential signals
Analysis of ongoing signal evaluation
Label update analysis

Literature Surveillance

Literature for reports of adverse events for all types of products, using standard terms, triage analysis, and relevant processing for expedited or periodic reporting

Medical Call Center

24*7 support
Tracking for Product Quality Compliant
Product Inquires and comments