Australia’s specialist in pharmacovigilance, GCP auditing and AI-enabled compliance.
We help sponsors, CROs, pharmacies, labs and research organisations build clear, auditable, inspection-ready safety and quality systems. Clients trust us for our GxP expertise, transparent workflows, and safe, human-in-the-loop AI deployment.
Our Expertise
At GxP Vigilance, we help regulated healthcare and life-science organisations build safer, smarter, and inspection-ready systems across the full GxP and AI operations lifecycle.
Our services combine pharmacovigilance expertise, independent GCP auditing, and AI-enabled compliance and business optimisation — giving teams the clarity, control, and confidence they need to operate at a higher standard.
We support sponsors, CROs, CTN holders, pharmacies, labs, medical device companies, and research organisations across Australia and New Zealand.
Whether you’re strengthening your PV system, preparing for a GCP inspection, or introducing AI-ready workflows aligned to ISO 42001 and modern data-integrity expectations, we design solutions that are practical, defensible, and built for real-world use.
Explore our core services below — each designed to help your team reduce risk, streamline operations, and stay consistently inspection-ready.
AI-Native Implementation: Building Capability, Not Just Reports
We don’t write 40-page reports and disappear. We build your system with your team, validate it, document it thoroughly, train your people to run it, and leave you capable — not dependent.
Modern AI-enabled consulting:
- Co-build with your team – Configure systems alongside you, document thoroughly, and transfer ownership
- Agent governance with human oversight – Clear controls, ownership, and audit trails built in from day one
- ISO 42001 and GAMP 5-aligned – AI lifecycle management meeting regulatory expectations
- Always-on monitoring – Immutable audit logs tracking accuracy, usage, and continuous improvement
What you get:
Working systems your team owns and can evolve. AI assists, humans approve. Every recommendation is traceable. When inspectors arrive, you show them governance in action — not theoretical frameworks gathering dust.
Meet our team
Behind every audit, assurance report, and compliance framework is a team built on clarity, control, and integrity.
At GxPVigilance, we combine regulatory experience, medical insight, and digital precision — creating a collaborative approach that strengthens both systems and people.
