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Expertise

Vigilance

From pre-market product safety to post-market surveillance and data analysis to meet your safety and compliance needs.

Our global safety and pharmacovigilance team collaborates with clinical operations, regulatory and others, to manage your safety and pharmacovigilance needs at any stage of product development to ensure quality and compliance.

Pharmacovigilance System

  • PSMF
  • EU QPPV services
  • Local QPPV services
  • Due diligence
  • Eudravigilance support
  • Inspection ready

Case Processing and Report

  • Validated safety database
  • SAE / SUSAR / ICSR
  • Reconciliation
  • Expedited reporting

Risk Management

  • Risk Management Plans / RMP
  • Aggregate reports : DSUR / PSUR (PBRER)
  • Signal detection activities / Signal detection management

VCLS Expertise