Drug Safety and Pharmacovigilance

DRUG SAFETY AND PHARMACOVIGILANCE

 Our experiences MDs and PhDs provide in-depth medical knowledge needed for medial review and assessment of safety data.
Our aggregate reporting team is well trained and extensively experienced across therapy areas to understand the global regulatory requirements.

End-to-End ICSR Processing

  • ARGUS/ARISg Safety Database Expertise
  • Medical Information Call center (24X7)
  • Literature Monitoring
  • Safety/Patient Narratives
  • Quality Review of ICSRs
  • Signal Detection and Management
  • Social Media Screening

PV Operational – Advisory Services

  • Compliance and Auditing Support (QMS support)
  • HA Inspection Readiness
  • PV Process-flow – System Implementation and Improvement

Aggregate Report Writing

  • Development Safety Update Report (DSUR)
  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Periodic Adverse Drug Experience Report (PADER)
  • Annual Safety Report (ASR)
  • Risk Management Plans (RMP)
  • Risk Evaluation and Mitigation Strategies (REMS)