About Us

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. The regulatory landscape is constantly changing and increasingly demanding for drug and device research and clinical trials. At Arbit Consulting LLC, we can save you time and unnecessary investments by providing regulatory education, strategy and support from concept to post-market monitoring. Doing the right things, the right way, at the right time.

Experience

Arbit Consulting LLC has the experience and knowledge to support your regulatory needs with over 50 years of experience in regulatory affairs, clinical research, quality assurance, product development, industry and academia including holding positions at:

  • Baxter-Travenol Laboratories

  • 3M Medical Products

  • Upsher-Smith Laboratories

  • Denvey Pharmaceuticals

  • SmithKline Beecham’s Diversified Pharmaceutical Services

  • Coloplast Skin Care

  • Regions Hospital

  • University of Minnesota’s Academic Health Center and College of Pharmacy

  • St. Catherine University Henrietta Schmoll School of Health Sciences

Presentations, workshop and training for:

  • Clinical researchers

  • Sponsor-investigators

  • Industry sponsors

  • Medical device companies

  • Pharmaceutical companies

  • Research staff

  • Clinical trial monitors

  • IRB staff

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Regulatory Certifications

Arbit Consulting is active in several professional associations in pharmacy, regulatory affairs and clinical research. We hold Regulatory Affairs Certification (RAC) through RAPS, Clinical Research Certification (CCRP) through SOCRA and have served on the board of directors of SOCRA as a board member and officer.

Proud member of Medical Alley

Proud member of Stripe

Harvey M. Arbit
PharmD, MBA, RPh, RAC, CCRP

Founder and Consulting Partner

Wrenda Teeple
PharmD, BCPS

President