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            Pharmaceutical
Advertising & Promotion 

WHAT ARE PEOPLE SAYing?

"Over the years Nancy has been a trusted advisor, a voice of reason and most of all a friend. Her legal talents are unparallelled, and always reflective of the current environment. Further, she approaches legal advice with creativity and an appreciation for compliant, real-life compatible solutions. Above all she is a pleasure to deal with. I hold her in the highest regard."

— Ron Guido, VP Regulatory

 

 

Nancy has almost 20 years of experience in promotional review and has served on over 20 review committees covering a wide variety of pharmaceutical products and therapeutic areas such as neurology, respiratory, digestive disorders, endocrinology, infectious diseases, women's health, men's health and oncology. She has also covered corporate communications. She is known for her pragmatic and collaborative approach.  

Nancy is a graduate of The University of North Carolina at Chapel Hill and Georgetown Law. Prior to starting her own practice, Nancy worked for over a decade in the FDA Regulatory practice of Hogan Lovells in Washington, DC.  In addition to her promotional review work, she helped defend clients in off-label False Claims Act cases and negotiate CIAs with the OIG.  She also conducted promotional material audits, assisted with internal investigations, and helped companies draft commercial policies.

 

Before her legal career, Nancy headed up a research department of a health care research and consulting firm in Washington, DC.

Education

B.A., The University of North Carolina at Chapel Hill, with honors (1997)

J.D., Georgetown University, magna cum laude, Order of the Coif, Georgetown Law Review (2004)

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Core Values

Deep Listening

We place an emphasis on deep listening and learning.  Understanding our business and other partners is critical to providing valuable advice and risk analysis.

Rigorous Analysis 

A strong background in the relevant FDA history, guidance and enforcement is the basis of our practice.

Clear Communication

We are committed to clear communication with all our partners.  We use plain language, not legal jargon.

 

Collaboration

 We believe that collaboration with our business, regulatory and medical partners is at the heart of what we do.        

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