Provide Food and Drug Administration (FDA)-related regulatory support to attorneys in cases involving; (i) death or injury caused by drugs, biologics, or medical devices, (ii) patents infringement, (iii) insurance claims, (iv) wrongful termination, (v) trade secrets, (vi) merger and acquisitions, (vii) stock fraud, (viii) software development, (ix) data integrity.

Worked on more than 50 cases, over 20 expert reports, more than 20 depositions, testified 5 times.

Hands-on experience in the entire lifecycle of FDA-regulated product development, from creating an initial regulatory strategy, thru protocol development, data collection, data analysis, and report writing, to review and approval at FDA.

Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it?

Education: 

• Ph.D. – Physiology, University of Georgia – Athens, GA
• M.S. – Physiology University of Maryland – College Park, MD
• B.A. – Biology, University of Iowa – Iowa City, IA

Additional Information: 

SEAK Experts 

LinkedIn