Steve Goldner, JAD RAC

Principal Officer, Regulatory Affairs Associates, LLC, West Bloomfield, MI

Steve Goldner founded Regulatory Affairs Associates (RAA) in 2001. RAA provides professional services to organizations to obtain regulatory approval (FDA and EMEA) and insurance reimbursement of drugs and medical devices. In addition to regulatory advice, this Michigan-based company also offers services related to biocompatibility, clinical trial management, legal matters, GMP and GCP compliance, SOPs, physician sample procedures, labeling and recall management. A chemist and an attorney by training, Steve has more than 30 years of experience as a regulatory professional. Throughout his regulatory career, Steve has developed both a strong track record of success and strong working ties with the FDA. These interactions have included work on NDA/ANDA, 510(k), and IND submissions, QA/QC validation and insured GMP compliance.