- FDA Resources
Arbit Consulting, LLC is a regulatory strategy and support company specializing in industry, academia, and investigator-initiated sponsored clinical research. Regulatory knowledge and support is provided for IND, IDE, PMA, NDA, BLA, and 510(k) submissions to FDA. Products supported include drugs, devices, cosmetics, nutritional supplements and combination products. Clients include startup companies, small established companies, academic institutions, medical centers, independent researchers, and law firms. Arbit Consulting brings decades of experience in industry and academia in a variety of positions in regulatory affairs, clinical research, quality assurance, and product development. We offer a variety of educational services including presentations, workshops and training to investigators, sponsors, sponsor-investigators, small-business owners, and other research staff regarding regulatory obligations. The regulatory landscape is constantly changing and increasingly demanding for drug and device research. At Arbit Consulting, we can save you time and unnecessary investments by providing regulatory education, strategy and support from concept to post-market monitoring.