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

Medical
Call Center

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

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