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.

Complete Pharmacovigilance Service Provision

Can your organisation conduct a full Pharmacovigilance service for your medicines with your current resources? We can provide advice or services for all aspects of Pharmacovigilance…

Personalised Pharmacovigilance Services

We can provide individual components of a Pharmacovigilance service that meet your requirements, including:

  • 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)

Preparing for Audits and/or Inspections

Do you have an imminent audit or inspection? Or an incomplete CAPA from a previous audit or inspection? We can provide expert advice on your current status and the steps you need to take to achieve a great outcome.

Client Audit Service

We understand how critical it is to possess current, compliant procedures. We also conduct routine regulatory intelligence to stay up-to-date with the regulatory landscape. We can perform an internal audit on your organisation and advise on compliance gaps, quality processes, procedures and industry best practices.

Risk Management

Need assistance with medicines risk management, or with preparation or submission of Risk Management Plans (RMPs) or Australian Specific Annexes (ASAs)? Our team can provide expert risk management advice and training to your organisation, or prepare or review RMPs/ASAs for you.