Benjamin P. Lewis, PhD

Title: Principal, President
Company: Lewis Regulatory Consulting, LLC
Location: Gaithersburg, Maryland, United States

Benjamin P. Lewis, Principal and President of Lewis Regulatory Consulting, LLC, has been recognized by Marquis Who’s Who Top Health Care Providers for dedication, achievements, and leadership in regulatory science.

Known for excellence in regulatory science, Dr. Lewis has become a much sought-after member of his professional community. He decided to start Lewis Regulatory Consulting, LLC, in 2008 to better help his peers, and he has been there as the principal and president ever since. His role includes filing INDs and NDAs for drug and orphan drug products to the Food and Drug Administration, Health Canada, and the EU for pharmaceutical companies. Previously, Dr. Lewis held positions like head of regulatory affairs in North America for Mitsubishi Tanabe Pharma Development America, Inc., vice president of regulatory affairs for Prestwick Pharmaceutical, Inc., managing director of the Brand Institute, Inc., and director of regulatory operations in the Division of Emerging and Transfusion of Transmitted Diseases in the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration, along with many more. The highlight of his career was creating a drug for people diagnosed with Huntington’s disease. Other notable achievements include designing, creating, and developing one of the first master’s programs in regulatory affairs and regulatory science in the U.S. at San Diego State University through the Food and Drug Administration, and creating and forming The Society of FDA Pharmacists. At the Brand Institute, he successfully created and obtained FDA approval of various brand names for marketed pharmaceuticals.

Dr. Lewis prepared for his endeavors by completing postgraduate work at Johns Hopkins University in 1993 and earning a PhD in health services management from Century University in 1989, a degree from the U.S. Army School of Aviation Medicine in 1973, a Master of Science in pharmacy from Auburn University in 1972, and a Bachelor of Science in pharmacy from Auburn University in 1966. He then furthered his standing by becoming a registered pharmacist in the states of Alabama and Kentucky, a credentialed inspector through the U.S. Food and Drug Administration, and certified in regulatory affairs through the U.S. Food and Drug Administration. To keep in touch with his peers, he joined prominent professional organizations like the Drug Information Association, the Association of Military Surgeons of the United States, the Regulatory Affairs Professional Society, the U.S. Food and Drug Administration Alumni Association, and Sigma Xi. He also connected with them through literature like “Combined Vaccines and Simultaneous Administration” and “Polio Virus Attenuation: Molecular Mechanisms and Practical Aspects,” of which he was the co-editor, and like “Orientation Book for CBER Advisory Committee Members,” of which he was the author.

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