Art has over forty years of increasingly senior management-level positions in the Pharmaceutical Industry. Particular expertise in the preparation of large, complex corporate and regulatory (NDA/BLA/MAA/PMA/510(k)) documents and thorough familiarity with relevant US, Canadia, EU, and ICH guidelines. He is a Registered Agent with US FDA, guiding ex-US companies through the regulatory processes required to initiate clinical trials and file successful applications for commercialization.
His additional expertise includes encompassing clinical, preclinical, promotional, and medical educational aspects of all phases of product research, development, and registration.
