FOR ANZ SPONSORS, BIOTECH, PV TEAMS & SOFTWARE PARTNERS
Pharmacovigilance built for Australia and New Zealand.
One modern cloud platform for adverse-event case management, regulatory workflows and safety reporting — designed around TGA and Medsafe requirements, hosted in Sydney, and supported in your timezone.
1ANZ-focused workflows
TGA and Medsafe CARM reporting steps, timelines and dictionaries are built in — not adapted from a US or EU template.
2Faster, simpler implementation
Live in 4–6 weeks at a fixed fee, with validation documents and your existing case data migrated — not an empty tenant.
3Less manual case-processing
AI-assisted intake, duplicate detection and MedDRA coding suggestions cut handling time on every case — a person still approves each step.
OPEN CASES
0
+12% MoM
SIGNALS DETECTED
0
3 new today
ON-TIME E2B
0.0%
TGA + CARM
ADVERSE EVENTS / WEEK
SUBMISSION PIPELINE
LIVE ACTIVITY
- Signal confirmed — Nurolex 50mg · disproportionality 2.4×now
- TGA deadline in 48h — AU-2026-01481 escalated to QC2m
- CARM submission accepted — NZ-2026-002939m
- AI triage coded 14 new cases with MedDRA 27.116m
The problem
Safety reporting in ANZ is harder than it should be.
If any of these sound familiar, the cost is already on your desk — in handling time, compliance risk and reports that arrive too late to act on.
45 min
typical manual handling per case
Cases arrive from everywhere — and get re-typed
Reports come in by phone, email, pharmacy software and literature screening. Teams re-key the same details into a safety database, which is slow and introduces transcription errors.
6–12 mo
typical enterprise PV implementation
Enterprise tools weren’t sized for ANZ teams
Global safety systems carry 6–12 month implementations, six-figure setup costs and workflows modelled on FDA and EMA needs — with TGA and Medsafe steps configured later, if at all.
100%
of actions need a defensible trail
Spreadsheets fail at inspection time
When the TGA or a sponsor auditor asks who changed what and when, shared drives and inboxes can’t answer. A defensible audit trail has to be automatic, not reconstructed.
Why VigilantLabs
Three reasons teams switch — and stay.
Built in Melbourne, for ANZ rules
Local by design
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 run natively, with jurisdiction-specific clocks on every case. Data stays in AWS Sydney under the Privacy Act 1988 (APPs) and NZ Privacy Act 2020 — and support answers in AEST/NZST.
4–6 week fixed-fee go-live
Weeks, not quarters
Implementation includes validation documentation, MedDRAThe standard medical dictionary used to code adverse events so every company and regulator describes the same reaction the same way./WHODrug dictionary setup and migration of your existing cases. You go live with your data in the system — not with an empty tenant and a professional-services invoice.
Assists every step, decides none
AI where it actually saves time
Intake extraction, duplicate detection, MedDRAThe standard medical dictionary used to code adverse events so every company and regulator describes the same reaction the same way. coding suggestions and disproportionality screening cut manual effort per case. A qualified person reviews and approves every output, and each AI suggestion is recorded in the audit trail.
Choose your path
One medicine-safety story, two ways in.
Reports are captured where healthcare happens, and managed where safety decisions are made. VigilantLabs connects both ends — pick the side that matches your role.
VigilantLabs PV Platform
For sponsors, biotech, CROs and PV teams
The complete safety database: case intake and management, regulatory workflows for TGA and Medsafe, full auditability, safety monitoring and reporting.
- Case intake, triage & management
- TGA / Medsafe / global submission workflows
- Audit trail on every action
- Signal detection & aggregate reporting
Embedded clinical reporting
For pharmacies, clinics and software partners
Adverse-event reporting embedded in the tools clinicians already use — like Fred Dispense Plus — so a report takes minutes and no detail is typed twice.
- Report inside the dispense screen
- Consent-based data pre-fill
- No switching systems, no re-entry
- Structured data straight to the sponsor
How the two connect: a pharmacist starts a report inside Fred Dispense Plus; it arrives in the sponsor's VigilantLabs safety database already structured and coded — checked, submitted to the regulator and monitored for signals, with no re-typing at any step.
See the product
From first report to regulator, in one workflow.
Every suspected adverse reaction becomes an ICSRIndividual Case Safety Report — the standard record of one patient’s suspected adverse reaction to a medicine. that moves through five stages — with the regulator's clock tracked automatically at each one.
- 1
Intake
Pharmacy, email, E2B import, literature
- 2
Triage & coding
Duplicate checks, MedDRA suggestions
- 3
Case management
Review, QC, medical assessment
- 4
Regulatory output
TGA E2B(R3), Medsafe CARM, global
- 5
Monitoring & insights
Signals, dashboards, PSURs
New case intake
via Fred Dispense PlusReporter
Pharmacist — TerryWhite Chemmart, VIC
Patient
Female, 67 — consent recorded
Suspect product
Cardivast 10mg (batch verified)
Event (MedDRA PT)
Rhabdomyolysis — serious
Automated checks
- Duplicate check — no match found
- Medicine verified against AMT
- Seriousness assessed — TGA 15-day clock started
Structured from the first touch
Reports arrive from embedded tools like Fred Dispense Plus, email import or 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. gateway. Medicines are verified against the AMT, duplicates are flagged, and the seriousness clock starts on receipt — not on data entry.
See this view with your own casesUse cases
What this looks like in practice.
Established sponsor · Melbourne
- Problem
- Legacy safety database retiring, TGA inspection on the calendar.
- How the platform helps
- Migrated 8,400 legacy cases with validated mapping and a complete audit trail.
- Outcome
- Inspection-ready in 5 weeks — no findings on case data.
Biotech · first product entering Phase III
- Problem
- Needed a compliant safety operation without an enterprise budget or timeline.
- How the platform helps
- Right-sized platform with TGA workflows, MedDRA coding and AI triage switched on from day one.
- Outcome
- Compliant from the first enrolled patient; scales with the pipeline.
CRO · 12 concurrent client programs
- Problem
- Case queues mixed across clients; no workload visibility for the team lead.
- How the platform helps
- Multi-client workspaces, per-client SLAs and workload dashboards.
- Outcome
- One team runs every program with consistent, auditable handling.
Pharmacy group · 200+ stores
- Problem
- Pharmacists spotted adverse events but reporting meant phone calls and forms after hours.
- How the platform helps
- Reporting embedded in Fred Dispense Plus — patient and medicine details pre-filled with consent.
- Outcome
- Reports submitted in minutes from the dispense screen.
MAH · high-volume inbox intake
- Problem
- Safety inbox triage consumed two full-time roles.
- How the platform helps
- Structured intake with AI extraction, duplicate detection and auto-coded drafts.
- Outcome
- 68% less manual handling per case in pilot programs.
Healthcare software vendor · ANZ
- Problem
- Customers asked for adverse-event reporting inside the product; building it in-house meant a compliance program of its own.
- How the platform helps
- Embedded reporting APIs and a consent-based integration pattern.
- Outcome
- ADR reporting shipped as a feature, not a compliance project.
Scenarios are representative of ANZ customer engagements; metrics shown are from pilot programs and implementation projects.
Trust & compliance
The detail your QA team will ask about.
Regulatory fit for 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 with acknowledgement tracking
- Medsafe CARMCentre for Adverse Reactions Monitoring — New Zealand’s national pharmacovigilance centre, run by Medsafe. reporting workflows for New Zealand
- ICH E2B, EMA GVP and FDA 21 CFR Part 11 aligned for global programs
- MedDRAThe standard medical dictionary used to code adverse events so every company and regulator describes the same reaction the same way. and WHODrug dictionaries maintained for you
Data protection you can show a board
- Hosted in AWS Sydney (ap-southeast-2); optional NZ backup residency
- Privacy Act 1988 (APPs) and NZ Privacy Act 2020 alignment
- AES-256 encryption at rest, TLS 1.3 in transit
- Hash-verified audit trail on every action, exportable for inspection
A team you can actually reach
- Support answered in AEST/NZST by people who know PV
- 4–6 week fixed-fee implementation with validation documentation
- Named response channel: hello@vigilantlabs.ai · +61 425 228 763
- Australian company — ABN 45 660 793 199, Melbourne
4–6 wks
typical ANZ go-live
99.8%
on-time regulatory submissions
100%
of actions audit-trailed
ROI calculator
What would VigilantLabs save your team?
Based on VigilantLabs licence bands and ANZ processing benchmarks. Adjust the inputs, then unlock your personalised breakdown.
Your operation
Your personalised results
Complete the inputs on the left, then unlock your personalised breakdown.
Modelling note: licence from annual case-band table; Enable AI add-on A$8,900/yr, Enterprise AI A$48,000/yr; setup A$25,000 one-time; gateways A$11,000 each; fees increase 10%/yr from year 2. Incumbent comparison uses vendor-quote benchmarks (A$150k setup, A$350k/yr) — replace with your actual quotes. Duplicate detection and avoided late-submission effort are additional unquantified benefits.
Straight answers
The questions ANZ buyers actually ask
Most ANZ customers go live in 4–6 weeks, fixed fee. That includes validation documentation, MedDRA/WHODrug dictionary setup, and migration of your existing case data — not just an empty tenant.
In AWS Sydney (ap-southeast-2) by default, with optional New Zealand backup residency. Australian data stays onshore unless you ask otherwise, and the arrangement is written into your agreement.
Yes. E2B(R3) submissions to the TGA and reporting workflows for Medsafe/CARM are built in, with jurisdiction-specific timelines tracked automatically on every case.
Transparent subscription tiers sized for ANZ biotech and pharma — from lean startup sponsors to multi-product MAHs. Every plan includes implementation, validation support, and AEST/NZST support hours. Book a demo and we will share indicative pricing on the first call.
Book a 20-minute demo.
Run from Melbourne, in your timezone. Bring your toughest case workflow — we will show it live in the product, not slideware.
What happens next: your enquiry goes straight to our Melbourne product team, and a named PV specialist replies within one business day (AEST/NZST) with a confirmed time and a short pre-read tailored to your setup.