Clinical development & operations expertise with regulatory strategy

Guiding Pharma/Biotech/MedDev companies through complex regulatory pathways to approval

With over 25 years of experience as a CRO founder and manager, I turn clinical and regulatory challenges into product approvals.

Let's Talk

EXPERIENCE

A unique dual perspective

25+

YEARS EXPERIENCE

30+

CBER/CDER/CDRH 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. Since consulting in 2013, 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, managing and obtaining input from multidisciplinary resource, backed by a proven track record of successful product registrations.

CRO Selection

Independent, experienced and 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 and mitigate risks.

FDA Representation

Expert guidance for Pre-IND, End-of-Phase II, and IDE meeting packages with extensive experience collaborating with the FDA.

Early FDA engagement saves both your time and resources

I frequently serve as the clinical representative for Sponsor teams during pre-IND/IDE preparations of Meeting Packages, focusing on key questions for the Sponsor that require FDA agreement. When Sponsors come prepared with relevant questions, the FDA is remarkably supportive. Engaging with the FDA early clarifies expectations before major investment and builds constructive relationships with your review team.