Arbit Consulting, LLC

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, and 510(k) submissions to the FDA. Arbit Consulting LLC brings decades of experience in industry and academia in a variety of positions in regulatory affairs, clinical research, quality assurance, and product development. We have submitted dozens of successful IND, IDE, 510(k), PMA, NDA and BLA applications in a variety of therapeutic areas including orphan drugs, expanded access drugs, oncology, dermatology, dentistry, pediatrics, cosmetics, as well as dietary and nutritional supplements.