To bring innovation to a dormant industry, to build a reliable & dependable team of experts, and to provide regulatory services and advice at the simple click of a button.
Robert (Rob) Merrill, JD
Rob specializes in assisting pharmaceutical, biotech and medical technology companies with global risk assessments, independent reviews and ethics and compliance program development. A representative sample of his experience includes developing global compliance programs in promotional compliance, sales and marketing practices, fraud and abuse laws, state laws, sample compliance, compliance training and compliance monitoring and auditing.
He has significant industry experience in the areas of healthcare compliance, regulatory affairs and risk management and past positions include Compliance Officer and Sr. Director of Regulatory Affairs. Rob received his B.S. in Biology from Utah State University and his J.D. from The John Marshall Law School in Chicago, Illinois.
Tracy Rockney, JD
Tracy is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. She is the Co-founder and Managing Partner at OneSource Regulatory. Her senior regulatory management experience included her former role as Vice President, Regulatory Affairs, Global Labeling, Advertising & Promotion, Regulatory Policy & Intelligence at AbbVie (formerly Abbott Pharmaceuticals), Senior Director, Global Regulatory Affairs at Shire Pharmaceuticals, Director, Regulatory Affairs at Wyeth, and Director, Global Regulatory Strategy at Pfizer. Tracy is a Board Advisor and Regulatory Officer in Residence for Doctor Evidence, a specialty software platform and services company that transforms clinical studies, drug labeling and epidemiological databases into reusable dynamic relational databases, and a Board Advisor for Daylan Pharmaceuticals, a start-up company conducting ophthalmology research.
Tracy is currently a steering committee member on the DIA.HBA Leadership Project which was formed by the Drug Information Association (DIA) and the Healthcare Businesswomen’s Association (HBA) to advance the careers of women in regulatory, medical, legal and compliance. She was a member of the FDLI planning committee for the 2012 Advertising & Promotion conference. Tracy received her Juris Doctor from Washburn University School of Law, and her Bachelor of Arts from the University at Albany, State University of New York, Rockefeller College of Public Affairs & Policy.