About

The principal consultant and founder is Mrs. Lan-Anh Chung, M.Sc. After working several years for a US medical device manufacturer as a Regulatory Affairs Manager in Europe, handling mainly clinical trial submissions, vigilance reporting, quality and project management as well as assisting in the filing of a PMA submission, she switched to a Regulatory Affairs Consultancy where she worked on numerous international projects from medical device to medicinal product trials submissions, vigilance reporting, product registrations with the Competent Authority, assisting with technical files and handling a drug-device combination project. Ms. Chung later on relocated to the US where she started to work as a Regulatory Affairs consultant assisting with clinical evaluations for medical devices and providing Regulatory Affairs consulting for a number of international clinical trials. CLINSTEP has been the successful evolution of this work. Mrs. Chung is fluent in German, French, English and Vietnamese.