David Schoneker

David R. Schoneker is currently the president/owner of Black Diamond Regulatory Consulting LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.

With over 47 years of experience working in these areas, Schoneker has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an adjunct professor at Temple University's School of Pharmacy in their RA/QA Master's Program teaching courses in global excipient regulations and the regulation of dietary supplements.

Prior to August 2019, Schoneker was the global regulatory director – strategic relationships at Colorcon Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. He was at Colorcon from 1977 until 2019. 

Schoneker was the chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee, the chair of the QbD/Composition Committee and is actively involved with the development of regulatory, safety, GMP and supplier qualification related guidelines to improve excipient and food additive quality and safety.

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