About Sue Bhadare

Bringing 25+ years of hands-on clinical development and regulatory expertise to biopharmaceutical companies worldwide

For more than two decades, I've partnered with start-ups, small biotech firms, and mid-sized therapeutics and medical device companies, with 90% being international clients navigating the U.S. regulatory landscape. My expertise bridges clinical development, regulatory strategy, and operational excellence.

Having been both a CRO owner and a Sponsor consultant gives me unparalleled insight into what makes partnerships successful—and what doesn't. I understand both sides of the table, which means I can help you avoid common pitfalls and maximize the value of your CRO relationships.

My Journey

2005

Entered Clinical Research

Started working with biopharmaceutical companies, specializing in regulatory strategy and clinical development for international clients entering the U.S. market.

1999

Founded CRO

Established and managed a Contract Research Organization for ten years, gaining invaluable insight into both sponsor and vendor perspectives.

2015

Focused on Clinical Operations

Transitioned to focus exclusively on clinical operations, CRO management, and process optimization—applying lessons learned from running a CRO.

Today

Strategic Partner

Serving as a trusted advisor to biotech and medical device companies, with deep expertise in FDA representation, Pre-IND strategy, and operational excellence.

"When Sponsors come prepared with relevant questions, the FDA is remarkably supportive. My role is to help you engage early, ask the right questions, and build constructive relationships with your review team."

— Sue Bhadare

How I Work

Hands-on Approach

I don't just advise—I roll up my sleeves and work alongside your team, creating documents, solving problems, and keeping studies moving forward.

Independent Perspective

As an independent consultant, I provide unbiased recommendations focused solely on your program's success.

Strategic Thinking

Every decision is informed by competitive intelligence, feasibility analysis, and a deep understanding of what FDA expects and what actually works.

Practical Solutions

I've seen what works and what doesn't. My solutions are grounded in real-world experience, designed to be operationally feasible & scientifically sound.

Beyond the Work

I'm based in downtown Nashville, Tennessee, where I enjoy the city's dynamic atmosphere and vibrant culture. Music City's energy and creativity inspire my approach to problem-solving in clinical development.

I'm also a proud parent of three accomplished adults who have launched their own careers. Watching them navigate their professional journeys reminds me of the importance of mentorship and supporting the next generation.

QUICK FACTS

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Based in Nashville, TN

30+ CBER meetings

Rare disease specialist

Former CRO founder

International Focus

Let’s Work Together

Ready to discuss your clinical development program?

Get in Touch