Strategic clinical development & regulatory expertise

I guide biopharmaceutical companies through complex regulatory pathways to approval

With over 25 years of hands-on experience and a unique perspective from founding and managing a CRO, I transform clinical and regulatory challenges into successful product registrations.

Let's Talk

EXPERIENCE

A unique dual perspective

25+

YEARS EXPERIENCE

30+

CBER MEETINGS

90%

INTERNATIONAL CLIENTS

ABOUT

From CRO founder to strategic advisor

For more than two decades, I've partnered with start-ups, small biotech firms, and mid-sized therapeutics and medical device companies navigating the U.S. regulatory landscape.

After founding and managing a Contract Research Organization for ten years, I bring an insider perspective to CRO selection and management that few consultants can match. For the past eight years, my focus has centered on clinical operations, CRO oversight, and process optimization.

SERVICES

How I can help

Clinical Operations

Hands-on operational support that keeps your studies compliant and on track. I create essential study documents and solve complex operational challenges.

Clinical Development

Strategic protocol development backed by a proven track record of successful product registrations. Designed for regulatory success.

CRO Selection

Independent, objective guidance in selecting the right CRO partner. My dual perspective ensures unbiased recommendations..

CRO Management

Complete Sponsor oversight when you need extension or don't have a full clinical operations department.

Quality Systems

Building quality into your operations from the ground up with practical, scalable systems that support compliance.

FDA Representation

Expert advocacy across Pre-IND, End-of-Phase II, and IDE meetings with deep experience presenting to FDA.

Early FDA engagement saves time and resources

I frequently serve as the clinical representative for Sponsor teams during Pre-IND Meetings. When Sponsors come prepared with relevant questions, the FDA is remarkably supportive. Engaging early clarifies expectations before major investment and builds constructive relationships with your review team.