Global Expertise. Practical Solutions. Audit-Ready Results.

Regulatory expertise built in the field, not in a classroom.

I spent 15 years working across the medical device industry — in laboratories, in manufacturing plants, in audit rooms, and across regulatory bodies in Europe, North America, and the Asia-Pacific region. Nearly a decade of that was spent working internationally, building a firsthand understanding of how regulators in different jurisdictions think, what they look for, and where companies most often fall short.

My background is scientific — a degree in Chemistry and a PhD in Pharmaceutical Sciences — but my career has always been at the intersection of science, quality, and regulation. Over time, that extended into areas that many regulatory professionals still treat as secondary: software validation, cybersecurity for medical devices, AI governance, and the growing convergence of digital health with traditional regulatory frameworks.

MD Regulatory exists to close that gap. Every document, checklist, and consulting engagement is built on real audit experience — not theory. The goal is always the same: help you get to market faster, pass your audit the first time, and build a QMS that works as a system, not just a compliance exercise.