Clinical Safety and Pharmacovigilance

Safety of a product is assessed all along its lifecycle , from early development , clinical trials , marketing authorization to post-marketing.

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

Pharmacovigilance

Pharmacovigilance System

  • PSMF
  • EU QPPV services
  • Local QPPV services
  • Due diligence
  • Eudravigilance support
  • Inspections ready
Pharmacovigilance

Case Processing and Report

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

Risk Management

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

Discover more services at VCLS

 

                    Regulatory Science

regulatory science