Where Human Insight Meets Intelligent Systems.

BioSyn-AI is an Australian AI company helping professionals and organisations work smarter, safer, and more compliantly — powered by our ecosystem of specialised AI agents and subject-matter experts.

3D neural chip illustration with glossy material finish and studio lighting, isolated on white.

Our Story — Why We Exist

Founded by Carl Bufe, a pharmacist, auditor, and AI strategist, BioSyn-AI was built on the belief that innovation should never outpace integrity.
Carl brings over two decades of experience in pharmacy, pharmacovigilance, and regulatory affairs across Australia, New Zealand, South Africa, and the UK. He’s helped organisations strengthen compliance, streamline systems, and adopt technology responsibly.
His passion lies in helping people feel confident about change — turning complexity into clarity and regulation into opportunity.
BioSyn-AI was created to bridge the gap between regulatory discipline and AI innovation, helping organisations adopt intelligent technologies without compromising safety, ethics, or trust.
Our philosophy is simple: Clarity. Partnership. Integrity.
We believe progress in healthcare and AI should always be purposeful, auditable, and human at its core.

What We Do – “Three Pillars of Practice”

GxP Vigilance

Regulatory vigilance & auditing.

GxP Vigilance

AI enablement & automation strategy.

Pharma AI Online Training Learning & professional growth.

Our AI Ecosystem – “Empowered by Intelligent Agents”

Carl 1.0

Personal Assistant to Carl (Ai Agent)

Carl 1.0 is an agentic research assistant dedicated to external intelligence.
Operating outside client systems, he monitors global trends in AI governance, regulation, and digital health.
Using a RAG framework, Carl 1.0 extracts, verifies, and reviews insights from trusted public sources.

Sophie

Content Developer

(Ai Agent)

Sophie is a Microsoft Azure–powered content and instructional design tool that helps builds and organises course materials, streamlining layout, structure, and flow.

Ailia

Quality Management

(AI Agent)

Ailia is a Microsoft Azure–powered governance and quality management tool that performs the heavy lifting in aligning training workflows and documentation with ISO 42001 and 9001 frameworks.

Tomas

Regulatory Advisor

(AI Agent)

Tomas is a Microsoft Azure–powered regulatory research and reference tool that locates, organises, and links relevant regulatory documents and global guidance to support the creation of current, compliant training content.