Services
Pharmacovigilance Services
Ensuring patient safety through proactive monitoring and compliance
Our pharmacovigilance team partners with clients to establish and maintain robust safety systems that comply with TGA, Medsafe, and EMA Good Pharmacovigilance Practices (GVP).
We deliver flexible solutions for both established and emerging organisations.
Adverse Event Case Management
- Collection, triage, assessment, and reporting of adverse events and product complaints within regulatory timelines.
Periodic Safety Reports (PSURs / PBRERs)
- Preparation and submission aligned with current regulatory requirements.
Signal Detection and Risk Evaluation
- Identification, assessment, and management of emerging safety trends using data-driven tools.
Pharmacovigilance System Master File (PSMF) Development
- Creation and maintenance of PSMFs to ensure GVP compliance.
Safety Data Exchange Agreements (SDEAs)
- Drafting, reviewing, and maintaining agreements between marketing partners.
Auditing and Compliance Support
- Internal audits and gap assessments to prepare for regulatory inspections.
Training and SOP Development
- Tailored training programs and SOPs to ensure continuous compliance and team readiness.
We don’t just manage safety data - we translate it into actionable intelligence for better health outcomes.