ABOUT USREV 2026.10

Built by people who lived the problem.

Alex Yue

Alex Yue, MBA

CO-FOUNDER
OWNS
QUALITY, REGULATORY AND THE CUSTOMER CONVERSATION
BUILT
Quality management systems for implantable medical devices, biologics and small-molecule pharmaceuticals
LED
Inspections by the FDA, EMA, TGA, PMDA and NMPA, and by BSI and TÜV SÜD
SEEN FROM
Compliance, from the operational and the audit side
RECOGNISED
BSI-certified QMS Lead Auditor
EDUCATION
Executive Master in Change, INSEAD · MBA, University of New South Wales

Alex built his career in life sciences, where quality decides whether a product reaches a patient at all. In these most regulatory-demanding environments, he built and maintained the quality management systems that help companies produce implantable medical devices, biologics, and small-molecule pharmaceuticals including sterile injectables and radiopharmaceuticals. As head of quality for multiple companies, he led inspections by the FDA, EMA, TGA, PMDA and NMPA, and by notified bodies such as BSI and TÜV SÜD.

As a BSI-certified QMS Lead Auditor and a quality leader, he has seen compliance from both the operational and the audit side, including the industry’s open secret: the “read and understood” signature that documents training without ever delivering the learning. That experience shaped his conviction that compliance training has to build genuine competence, not just the paperwork that proves it happened.

With an Executive Master in Change from INSEAD and an MBA from the University of New South Wales, Alex pairs deep regulatory experience with the commercial and organizational perspective to scale neolumi where compliance pressure is greatest.

In Stealth, PhD

CO-FOUNDER
OWNS
ENGINEERING, AI, INFRASTRUCTURE AND SECURITY
BUILT
Software and AI products for financial services and pharma, from compliant customer onboarding to AI tools inside pharma
LED
A team of engineers, business analysts and designers
SEEN FROM
AI, from the business and the engineering side
RECOGNISED
Two prizes for his doctoral research
EDUCATION
PhD in Aerospace Engineering · graduate studies in Mechanical Engineering

He built his career in regulated industries, where a system has to be explainable to the person who signs for it. In these environments, he built the software and AI products that help companies in financial services and pharma work faster without losing control, from compliant customer onboarding to AI tools that raise productivity and quality inside pharma. Along the way, he hired and led a team of engineers, business analysts and designers, and oversaw the cloud infrastructure his AI tools run on.

As a product manager and a hands-on developer, he has seen AI from both the business and the engineering side, including the question regulated industries keep running into: an output nobody can trace back to its source, its version, or the person accountable for it. That experience shaped his conviction that AI in a regulated company has to do the work, not have the last word.

With a PhD in Aerospace Engineering, where his doctoral research won two prizes, graduate studies in Mechanical Engineering and a background in strategy consulting, he pairs deep technical expertise with the commercial perspective to build neolumi’s training and compliance assessment.

Why neolumi

In regulated life sciences, compliance with standards and regulatory requirements is not optional, and neither is training. Assessing where compliance stands has always been a tedious, time-consuming task. The same goes for training, where every SOP revision can mean a large retraining burden or a risk of nonconformance. A significant part of the quality team's time is spent on work that should never have been done by hand.

neolumi was founded to fix that. We build AI tools that eliminate the manual busywork of GxP compliance, so quality teams can stay inspection-ready without drowning in paperwork.

DEMO REQUESTREV 2026.10

Book a demo

It goes to a person, not a queue. Bring an SOP you dread revising and we will run it through in front of you.

A FOUNDER REPLIES IN 2 TO 3 BUSINESS DAYS