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 37 cases, 16 expert reports, and 8 depositions. 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.