Regulatory Strategy and support 

for industry, academia, and investigator-initiated clinical research


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 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, 510k, PMA, NDA and BLA applications in a variety of therapeutic areas including orphan drugs, expanded access drugs, oncology, pediatrics, cosmetic, as well as dietary and nutritional supplements. The regulatory landscape is constantly changing and increasingly demanding for drug and device research and clinical trials. At Arbit Consulting, we can save you time and unnecessary investments by providing regulatory education, strategy and support from concept to post-market monitoring.