I am an FDA regulatory expert witness and an FDA compliance consultant skilled in the regulations and submissions of drugs, biologics and medical devices. In 2019, I completed a 3-year contract providing FDA regulatory advice to senior Army leadership in their pursuit of FDA approval for 15 products (drugs, vaccines, and medical devices) intended as defense against biological weapons.

I apply my broad and deep knowledge and experience as a biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert to assemble what might appear to others to be unconnected facts and regulations, but what I use to create easy to understand opinions reinforcing your legal strategy.

My goal is bomb-proof opinions that checkmate the opposition.