Juan Carlos Serna
Juan Carlos Serna has over 18 years of experience in leading FDA-regulated industries with preclinical and clinical biotechnology research, clinical trials, regulatory affairs and quality assurance.
He offers extensive best-practices experience in medical device regulations, IND/NDA regulatory submissions, Good Clinical Practices (GCP), Quality System Regulations (QSR), Good Clinical Data Management Practices (GCDMP), Good Laboratory Practices (GLP), and executing regulatory submissions including many 510(k) submissions across a broad span of areas.
director, regulatory intelligence
Elizabeth FitzGerald has a strong background in preparing regulatory filings pursuant to FDA data standards, with experience developing EDC and software applications for FDA-regulated companies. She leverages her skills in biostatistics, data analysis, and FDA strategy to meet medical device and biotechnology companies' regulatory needs.
She holds a Master of Science in Public Health from the Harvard University School of Public Health and earned a certificate in Biostatistics from the University of California San Diego Extension School.
co-founder & CEO
Marek Herrmann-Nowosielski has had an extensive career leading R&D, product development, operations, engineering and commercialization organizations and activities for established and venture funded companies in highly regulated industries, including leadership roles at GE, DuPont, Oasys Water and Heartland Technologies.
He is a Fellow of the Institute of Chemical Engineers, a registered Professional Engineer and holds MA, MSc, MEng and MBA degrees.