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 15 depositions, testified 3 times. I have never been successfully Daubert challenged.
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.