e-Consulting

Vigilance Services

"Next-generation Pharmacovigilance"

Azierta’s team of experts provides strategic and operational support for partial or full outsourcing of pharmacovigilance (PV) responsibilities.

With more than 10 years providing PV services, our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.

Our flexible PV solutions activities meet needs from early development to post-marketing of medicinal products.

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Postauthorisation
Vigilance
Clinical Trial
Vigilance

Human Medicines

Veterinary Medicines

Medical Devices

Cosmetic Products

- Find out our solutions -

  • EU-QPPV and deputy
  • UK-QPPV and deputy
  • Local-QPPV
  • Pharmacovigilance System Master File (PSMF)
  • Standard Operating Procedures (SOP)
  • Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEAs)
  • PV Compliance: Metric and KPIs
  • PV AuditsSupporting during health agency inspections
  • PSUR/PBRER
  • RMP
  • DSUR
  • ACO
  • Medical Literature Monitoring (MLM) service
  • Global Literature Monitoring in global databases (PubMed, EMBASE)
  • Local Literature Monitoring in non-indexed scientific journals
  • SAE/SUSAR during clinical trials
  • ICSR on market products
  • Vigilazierta, our global and validates safety database
  • Registration of “New organisation” as non-sponsor
  • Registration of responsible person (RP) of pharmacovigilance
Multidisciplinary scientific knowledge
Digital innovation
Go-to-market models
Global approach
with local support
Support throughout the value chain
Global
offering

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