Partnering for safety, regulatory compliance, and smarter systems.

Who I Am

I’m Carl Bufe — a husband, father, pharmacist, auditor, and AI enthusiast dedicated to medicine safety, regulatory affairs, and responsible innovation in healthcare.

With over two decades of experience across hospital pharmacy, pharmacovigilance, regulatory affairs, clinical trials, auditing, and AI governance, I help organisations and professionals build safer, smarter, and more efficient systems.

My work focuses on integrating quality systems, training, AI enablement, and ethical automation to improve patient outcomes and operational performance — ensuring compliance remains clear, sustainable, and human.

What drives me isn’t technology or paperwork — it’s people.
Behind every report is a patient who deserves safety, and a professional who deserves the correct tools.

Travels and learning

I’m a healthcare professional who’s worked across Australia, New Zealand, South Africa, Singapore, the UK, India and the USA—bringing pharmacovigilance, GxP auditing, clinical trials and AI governance together to strengthen medicine safety and quality.

As a Director, Quality Systems Lead Auditor, and Senior Hospital Pharmacist, I’ve built and reviewed audit-ready systems, trained teams, and supported sponsors and CROs in meeting global expectations with clarity and confidence.

Today I work through BioSyn-AI and GxpVigilance to help organisations implement responsible AI, streamline quality frameworks, and stay inspection-ready—always keeping patients first. I’m also a regular presenter, delivering live workshops, masterclasses, and in-person sessions that translate complex requirements into practical steps teams can use the next day.

Friendly, global and hands-on—that’s how I help teams build clarity, control, confidence and integrity into everyday practice.