Richard Schwen


Richard Schwen

Richard J. Schwen, PhD, DABT, RAC

Board Member, Strategic Regulatory Consulting


Dr. Schwen brings to SRC 23 years in the pharmaceutical industry.  While at The Procter & Gamble Co. he gained hands-on experience in toxicology, drug discovery and global regulatory affairs for many Rx and OTC therapeutic categories.  He later joined Kendle International, where as Vice President he led the global regulatory, safety and clinical quality assurance organizations.  This experience included leadership of the AAC consulting group, with over 50 ex-FDA officials.  Dr. Schwen later joined Parexel International in Waltham, MA, where as Vice President he led the regulatory and clinical quality assurance organization for the Americas.

In joining SRC, Dr. Schwen brings back to Cincinnati his leadership and experience in the drug development consulting business.  Dr. Schwen received his PhD in pharmacology from the University of Minnesota, and he is board certified in toxicology and regulatory affairs.  Dr. Schwen is also an Adjunct Professor at the University of Cincinnati College of Pharmacy, where he lectures in preclinical drug development and regulatory affairs.

Gayle Entrup has 25 years’ editorial experience in medical writing, journal submissions, and educational materials.  For the past 10 years she has also managed quality assurance audits of clinical study reports, labeling requirements, and patient narratives.  Experience includes analysis of data from case report forms and various databases.