AI-Native GxP implementation and transparent vendor auditing — where regulation, technology, and people meet.
What we do
We help regulated teams get back ahead when compliance work becomes unmanageable.
Our five core services:
- AI-Enabled GxP Transformation – automation under ISO 42001; human-in-the-loop by design.
- Pharmacovigilance System Design & Auditing – A-PVCP/QPPV models, ICSR workflows, literature & signal oversight.
- Good Clinical Practice (GCP) Auditing – independent audits aligned with ICH E6(R3)/TGA expectations.
- Capability Building & Training – practitioner-level enablement so teams own their systems.
- Business Consulting & Compliance Strategy – align growth, quality, and AI governance without adding risk.
Who we are
Led by Carl Bufe — The AI-Native GxP Practitioner (QPPV, Pharmacist, ISO 9001/13485/42001 Lead Auditor) with 24 years across Pharmacovigilance, vigilance, quality, clinical research, pharmaceutical compounding and pharmacy.
Based in Brisbane, with an office in Sydney, we serve Australia, New Zealand, and APAC.
We scale with trusted subject-matter partners and use client-approved AI providers. Our ISO-aligned internal AI agents (Microsoft 365/Copilot, Azure OpenAI, Anthropic, Gemini) streamline operational aspects, QMS, document control, and regulatory intel—accelerating delivery and consistency—while keeping client data out and preserving audit independence.
Why we exist
Compliance work has become unsustainable. PV backlogs outpace team capacity. Manual processes consume most of the day. Audit findings repeat despite best efforts. Good people burn out. Sponsors need reliable vendor oversight across APAC.
We exist to help teams get back ahead. We step in where pressure is highest—building pharmacovigilance systems, conducting independent vendor audits, implementing validated AI workflows, designing quality frameworks. Not writing reports from the sidelines—building working systems and transferring capability so teams own them.
Patient safety non-negotiable. Independence maintained. Human judgment where it matters. Fast AND safe. Teams back ahead.
GxPVigilance’s Values
Clarity — Plain-English guidance and clean artefacts so everyone knows what, why, and by when.
Control — Traceable, documented workflows with clear ownership so your team runs the system.
Confidence — Proof you can present, with reproducible results and full traceability.
Integrity — Patient safety first; human-in-the-loop, no shortcuts, no black boxes.
Authenticity — Practitioner-made, audit-tested solutions we’d use ourselves.
Partnership — Co-designed, transparent, with capability transfer so you stay independent
Beliefs
Compliance should enable improvement, not fear.
AI is a tool for clarity, not a shortcut around responsibility.
Teams should own their systems — not rent dependency.
Transparency builds trust with regulators and patients.
- Expertise should be shared and built, not hoarded
- Patient safety remains non-negotiable
Quality & AI Governance
ISO 9001 and ISO/IEC 42001–aligned controls with full traceability, human-in-the-loop oversight, and patient-safety-by-design.
What Makes Us Different
Dual Mastery – GxP + AI in one practice.
Implementation Focus, Not Assessment-Only
Patient Safety Non-Negotiable
Pharmacist and Builder – not just consultant.
Australian TGA and International Context Expertise
Training-First Approach – we transfer knowledge.
Testimonials / Motivations
GxPVigilance helped us clear a 2-month backlog in 2 weeks.