Regulatory Consultants
Diane Mandell Horwitz, Ph.D., RAC
 
Diane Mandell Horwitz is the President of Mandell Horwitz Consultants LLC, a firm that provides consulting services in the Washington D.C. area.  Diane has 20 years of consulting experience and specializes in the development of regulatory strategies and submissions to the Food and Drug Administration, particularly in medical devices.  The Firm’s focus is to assist manufacturers, both small startup firms as well as large corporations, to fulfill their regulatory responsibilities with careful attention to detail and scientific excellence while considering the limited budget, especially for the early development program.  
 
Among other activities, Diane works to develop strategies for diagnostic and therapeutic products, prepares submissions for FDA and represents clients to the Agency, assists with complaint handling, recalls, and other post-marketing issues, performs Quality System audits and due diligence assessments, and serves as the U.S. Agent for foreign medical device manufacturers.
 
Diane earned a B.S. degree in Animal Sciences from Cook College, Rutgers University, and received her Ph.D. in Physiology from the University of Medicine and Dentistry of New Jersey/Rutgers Medical School.  Diane was an Assistant Professor of Physiology at the Uniformed Services University for the Health Sciences in Bethesda, MD prior to beginning her regulatory sciences career.  She is a member of the Regulatory Affairs Professional Society and has received her RAC Certification.  Diane is currently enrolled in the Johns Hopkins Bioscience Regulatory Affairs Master of Science program.
 
Quality Statement
 
Mandell Horwitz Consultants LLC is committed to Quality and Excellence in scientific consulting, and strives to provide customers with the most streamlined and cost-effective approach to marketing safe medical devices and medical products in the shortest timeframe possible.
 
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