Denise Smart Email & Phone Number

As President of Smart Consulting Group, I have over 30 years’ of Life Science industry-specific manufacturing and quality experience with such companies as SmithKline Beecham, DuPont, Wyeth, Pfizer and Schering-Plough. With a broad range of experience in providing FDA regulatory compliance consulting services, I have a true passion for providing solutions to the Life Sciences industry's most difficult and complex challenges. I hold a BS in Biology from Kutztown University, a MBA from Penn State, and a JD from Widener Law School. I have been admitted to the Delaware Bar and the Federal District Court, District of Delaware. While attending Widener University School of Law, I realized my instinctual passion for health and corporate law, which led to a desire to start my own pharmaceutical consulting firm right in the borough of West Chester, Pa. I am a certified Women’s Business Enterprise (WBENC) business owner, meaning that I am dedicated to continually gaining relationships with local women owned businesses as a way to ultimately provide a sense of community for women entrepreneurs in the region, like myself. My expert team at Smart Consulting Group focuses on quality compliance, regulatory affairs, training, product/process development/manufacturing, laboratory services, project management. The SCG team also provides highly specialized services to the government supporting the Biological Advanced Research and Development Authority (BARDA) within HHS, serving as Interim Monitor of pharmaceutical divestitures for Federal Trade Commission and providing strategic regulatory compliance advice to the FDA. I am dedicated to providing outstanding technical and regulatory services to SCG’s client base as a way to truly change the nature of this industry.

Listed skills include Fda, Biotechnology, Gmp, Pharmaceutical Industry, and 28 others.