Regulatory education, strategy and support that saves you time and unnecessary investments.

For clinical researchers, investigator-initiated and sponsored research, clinical trial staff, industry, and academia.

Regulatory education, strategy and support that saves you time and unnecessary investments.

For clinical researchers, investigator-initiated and sponsored research, clinical trial staff, industry, and academia.

Save time and money by doing the right things, the right way, at the right time

Optimize your drug and device development regulatory strategy by working with us. We will navigate the FDA regulations with you to avoid wasting resources and duplicating efforts.

Make regulatory compliance easy

With our detailed and thorough approach to regulatory compliance and support, you can focus on research and product development. Grow your research program or business with us.

Build credibility with the FDA

Integrity is fundamental to our business. We ensure your relationship with the FDA is built on trust.

What clients are saying

  • “Wrenda’s phenomenal attention to detail, thorough knowledge of FDA guidelines, unimpeachable ethics, logic, and focus on patient safety gave me confidence in our path to success.”

    - Clinical Laboratory Director

  • "Harvey has been our FDA advisor for over a decade and has expertly guided us through the myriad regulatory requirements needed for our two medical devices: one to market and the current one ready for market. He makes the "journey" easy."

    - Eric Schiffman DDS, MS, Director of Clinical Research, School of Dentistry, Co-owner of the Restful Jaw, Co.

  • "Working with Arbit Consulting was incredibly helpful. They guided us through typical procedures for working with regulatory agencies, and helped us prepare our material and responses. The Arbit team responded immediately to our needs."

    -NIH-funded Clinical Investigator

  • "Our market research and strategic planning agency has worked with Arbit Consulting over the past 10 years and I would strongly recommend them. Arbit Consulting has always exceeded our expectations in terms of the quality of their analysis, the integrity of their recommendations, and the value of their insights."

    - Doug Kretchmer, CEO, The Green Edge, Inc.

  • "Harvey and his team provided excellent assistance and support for our clinical trial from running the protocol through getting our investigational new drug application approved and providing support in all aspects of the trial. I have worked with him on multiple projects and been connected with the industry for many years, Harvey and his team stand out."

    - Clinical researcher and Surgeon

  • "Dr. Arbit is a valuable resource for my classes on clinical research with his clear and knowledgeable teaching. Graduates of the program have also profited from his consultation."

    - Physician, Professor of Medicine

  • "Harvey and Wrenda are a pleasure to work with and have provided timely and good service at a fair price in handling our FDA correspondence and helping us with our regulatory obligations as pharmaceutical companies with drugs in clinical trials. "

    -CEO, Founder of Pharmaceutical Startup Companies

  • "Dr Arbit is a valuable resource for my classes on Clinical Research with his clear and knowledgeable teaching. Graduates of the program have also profited from his consultation."

    -Russell V.Luepker, MD, MS, Mayo Professor, University of Minnesota