Proven experience. Established processes. Responsible AI. Reliable outcomes.
As an independent Australian GxP consultancy, GxP Vigilance helps pharmaceutical sponsors, CROs, investigator sites, and research teams turn complex regulatory obligations into clear, auditable practice. Our services span pharmacovigilance
system design and auditing, GCP and GVP auditing, AI governance and validation, capability building, and strategic advisory — all delivered by a practitioner with 24 years of hands-on experience across TGA, ICH, and international regulatory environments.
Every engagement is risk-based, traceable, and documented to an inspection standard.
Where AI adds value, it operates under ISO/IEC 42001-aligned governance with human-in-the-loop review at defined approval points. The result: evidence you can show a regulator — and a team that moves with clarity, control, and confidence.
Explorer our Services
Pharmacovigilance Services Australia
Independent pharmacovigilance system design, QPPV and A-PVCP provision, ICSR management, signal detection, and TGA inspection readiness for Australian pharmaceutical sponsors. Systems built for your products and obligations — not global templates retrofitted to a local context.
Good Clinical Practice (GCP) Auditing in Australia
Risk-based GCP audits aligned to ICH E6(R3) and TGA inspection expectations — covering sponsor systems, investigator sites, vendor qualification, and due diligence for international organisations assessing Australian CROs. Findings documented to inspection standard with practical CAPA guidance.
Pharmacovigilance Auditor Australia
Independent GVP audits assessing how your pharmacovigilance system actually operates — evidence, traceability, SDEA governance, escalation pathways, and CAPA effectiveness. Available across Australia and New Zealand, with mock TGA inspection support and pre-inspection gap analysis.
AI Governance & Strategy
Governance-first AI adoption for pharmaceutical teams — ISO/IEC 42001 and GAMP 5 aligned, with defined scope, documented controls, human-in-the-loop oversight, and audit trail requirements built in from the start. Covers AI readiness assessments, governance framework design, vendor evaluation, and independent validation to support regulator questioning.
AI Integration & Workflow Systems
Practical implementation of validated AI workflows across pharmacovigilance, regulatory affairs, clinical operations, and quality systems — using tools your team already has. Every workflow is documented, tested, and designed for capability transfer so your team runs it independently.
AI Enablement & Capability Building
Structured AI enablement for regulated pharmaceutical teams — from initial readiness assessment through pilot design, governance framework, and hands-on capability transfer. The goal is a team that can govern, operate, and evolve their AI systems without external dependency.
Common Questions and Answers
What GxP services do you provide in Australia?
GxP Vigilance provides independent pharmacovigilance system design and auditing, GCP auditing, GVP auditing, AI governance and validation, AI workflow implementation, capability building, and strategic compliance advisory — all delivered by a practitioner with 24 years of experience across TGA, ICH, EMA, and FDA regulatory environments. Services are available to pharmaceutical sponsors, CROs, investigator sites, and healthcare organisations across Australia, New Zealand, and APAC.
How is GxPVigilance different from a large CRO?
You work directly with the principal consultant — not a junior associate managing 50 accounts. Every system we build is designed specifically for your products, your obligations, and your operational capacity. There are no global templates retrofitted to TGA requirements, no formal Change Orders for simple adaptations, and no dependency built in. Capability transfer is part of every engagement — the goal is a team that can run their systems independently.
Do you work with international sponsors operating in Australia?
Yes. A significant part of the practice serves US, European, and Asian sponsors who need ground-truth assessment of Australian CROs and investigator sites, or who require TGA-specific pharmacovigilance and GCP support for their Australian programs. Vendor qualification audits, due diligence assessments, and QPPV/A-PVCP service models for international sponsors are all standard
engagements.
What does AI governance in a GxP environment actually involve?
It involves defining which AI tools are used, for what purpose, under what controls, with what human approval points, and how outputs are
documented. In practice: risk assessment of AI use cases, human-in-the-loop design, audit trail requirements, change control for AI model updates, and validation documentation that supports regulator questioning. GxP Vigilance aligns all AI governance work to ISO/IEC 42001 and GAMP 5 Second Edition.
Can you support both pharmacovigilance and GCP in the same engagement?
Yes. Sponsors running clinical programs alongside post-market safety obligations often benefit from a combined audit and advisory engagement covering both GCP compliance and PV system readiness. A combined approach avoids duplication, identifies cross-system gaps — particularly around serious adverse event escalation and expedited reporting — and produces a unified CAPA plan rather than two separate remediation tracks.
Are your services available remotely or on-site?
Both. Most pharmacovigilance system design, AI governance, and training engagements are delivered remotely with structured document review and video sessions. GCP and GVP audits are available on-site or remotely depending on scope and client preference. For international due diligence engagements, on-site assessment within Australia is standard. We are based in Brisbane with a Sydney office and serve teams across Australia, New Zealand, and APAC.
How do I know which service is right for my situation?
A 30-minute scoping call is the right starting point. Most clients arrive knowing they have a compliance gap or an upcoming inspection — not necessarily knowing exactly which service addresses it. The scoping call maps your situation to the correct engagement type, gives you a clear picture of scope and timeline, and costs nothing.
Book a scoping call here.
GxP Vigilance
Questions specific to your programme?
A 30-minute scoping call costs nothing and leaves you with a clear
picture of where you stand and what to do next.