My operating principle is the truth makes the best story!

I am an FDA Regulatory Expert Witness and an FDA compliance consultant skilled in the regulations and submissions of drugs, biologics and medical devices. My experience includes 50 cases, 22+ expert reports, and 20+ depositions, testified 5 times. I have never had an opinion excluded because of a Daubert challenge.

I have broad and deep knowledge and experience as a biological scientist, statistician, software
developer, data integrity specialist, technical writer, educator, and FDA regulatory expert.