Regulatory Strategy and support for industry, academia, and investigator-initiated SPONSORED 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.
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