50+ years’ experience in pharmacovigilance

Our local team of experienced industry professionals has a cumulative 50+ years’ experience in Pharmacovigilance. We work collaboratively with clients to understand their Pharmacovigilance needs and to deliver services that meet their individual requirements.

  • Local Qualified Person for Pharmacovigilance (QPPV)

  • Pharmacovigilance training

  • Pharmacovigilance agreements (PVAs)/safety data exchange agreements (SDEAs) advice or preparation

  • A complete Pharmacovigilance service for a certain portfolio only

  • Post-marketing surveillance services or advice, e.g. adverse event reporting (ICSRs) or periodic safety reporting (creation and/or submission of PSURs/PBRERs)

  • Regulatory Intelligence

  • Global or local literature screening

  • Preparation of Risk Management Plans (RMPs) and Australian Specific Annexes (ASAs)