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 FDA. Products supported include drugs, devices, botanical drugs, cosmetics, nutritional supplements and combination products. Clients include startup companies, small established companies, virtual companies, academic institutions, medical centers, independent researchers, and law firms. With decades of experience in industry and academia, 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, oncology, pediatrics, as well as dietary and nutritional supplements.

 

In addition to regulatory strategy and support, Arbit Consulting LLC and its affiliates also offers a variety of educational services including presentations, workshops and training to investigators, sponsors, sponsor-investigators, small-business entities, clinical trial support teams and other research staff regarding their regulatory obligations. Arbit Consulting LLC has the experience and knowledge to support your regulatory needs with two book publications, over 90 presentations to research professionals at a range of local and international conferences and meetings and over 20 additional publications in journals and online. Arbit Consulting and its affiliates have over 40 years of experience in clinical research, 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, and the University of Minnesota’s Academic Health Center and College of Pharmacy. 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.



Harvey M. Arbit, PharmD, MBA


Dr. Harvey Arbit received his bachelor’s degree in pharmacy from Albany College of Pharmacy, his PharmD from Duquesne University and his MBA from Northern Illinois University. He completed a residency in clinical hospital pharmacy at Mercy Hospital in Pittsburgh, Pennsylvania. He joined the pharmaceutical industry straight from graduate school and has spent over 30 years there in the areas of regulatory affairs, clinical research, quality control, and product development. In 2002 the University of Minnesota’s Academic Health Center established the IND/IDE Assistance Program. Dr. Arbit joined the University of Minnesota to head up this new program, develop its policies, procedures and guidance documents, and launch the program university-wide. This program is recognized as a model for IND/IDE assistance in academic institutions. He was also the Leader for Regulatory Knowledge and Support in the Clinical and Translational Science Institute. He had oversight of the IND/IDE Assessment Program in the Research Integrity and Oversight Programs in the Office of the Vice President for Research. He continues to hold a faculty appointment as adjunct professor in the Department of Pharmaceutical Care and Health Systems at the University of Minnesota, College of Pharmacy. Dr. Arbit is an active member of several professional associations in pharmacy, regulatory affairs and clinical research. He has his Regulatory Affairs Certification (RAC) through RAPS and his Clinical Research Certification (CCRP) through SOCRA. He has served on the board of directors of SOCRA as a board member and officer.

To learn more about Dr. Arbit, visit his profile page here


Wrenda M. Teeple, PharmD


Dr. Wrenda Teeple received her Bachelor of Science degree in chemistry from the University of Minnesota Institute of Technology. Wrenda worked as a Building Coordinator for research labs at the University of Minnesota for over 5 years; serving as a 24/7 liaison responsible for maintaining building and laboratory safety and security standards in compliance with Department of Environmental Health and Safety (DEHS), Occupational Safety and Health Administration (OSHA) and other local, state and federal regulatory requirements. She went on to graduate summa cum laude with distinction from University of Minnesota College of Pharmacy with her PharmD degree and a Research Emphasis in Experimental and Clinical Pharmacology. Following her residency at Regions Hospital; Wrenda joined Arbit Consulting, LLC as Senior Regulatory Affairs Specialist and continues to work part-time as a Clinical Pharmacist at Regions Hospital. She has  provided regulatory strategy and support on a number of projects including IND and IDE submissions, Q-Sub meetings, Early Feasibility Studies, Expanded Access studies, clinical monitoring, annual reports, adverse event reporting, protocol development and amendments. Over the last 10 years Wrenda has been involved with multiple clinical research projects at the University of Minnesota, Regions Hospital and Children’s Hospital and Clinics of Minneapolis including assisting with grant applications, developing study protocols, IRB submissions, completing data collection, data validations, and preparing manuscripts. Wrenda’s professional areas of interest include investigator-initiated clinical research, patient and study participant safety and adverse event reporting, teaching, and pharmacogenomics. In her free time, Wrenda enjoys running, obstacle course racing, traveling and cooking. 

To learn more about Dr. Teeple, visit her profile page here