For ANZ pharmaceutical sponsors
Local obligations, handled locally.
You carry MAH responsibilities to the TGA and Medsafe. VigilantLabs gives you local regulatory workflows, full case visibility and an audit trail that stands up to inspection — without a global-system implementation.
What changes for your PV team
Regulatory ops, natively ANZ
TGA E2B(R3)The global electronic format regulators (TGA, Medsafe, EMA, FDA) use to receive safety reports. Think of it as the required envelope for an ICSR. submissions and Medsafe CARMCentre for Adverse Reactions Monitoring — New Zealand’s national pharmacovigilance centre, run by Medsafe. workflows with per-jurisdiction clocks on every case. EMA and FDA pathways when you need them.
Case visibility, end to end
From first report to submission acknowledgement, every case shows its stage, owner and deadline. No more chasing status over email.
Auditability without effort
Every action — human or AI — is hash-verified and timestamped. TGA inspections and sponsor audits get a one-click export.
Signals, not just storage
Continuous disproportionality screening across your AU and NZ case volume, with review queues your medical team actually works from.
Data residency you can sign off
AWS Sydney hosting, Privacy Act 1988 (APPs) and NZ Privacy Act 2020 alignment — written into your agreement.
Implementation in weeks
4–6 weeks, fixed fee, with your legacy cases migrated and validation documentation delivered.
See your own case workflow in the product.
Bring a real case scenario to a 20-minute demo — we’ll run it through intake, review and TGA submission live.
Or call +61 425 228 763 · answered in Melbourne, AEST/AEDT