OneSource Regulatory is a consulting firm specializing in pharmaceutical advertising and promotion compliance, medical review, pharmaceutical labeling development, regulatory strategy development, and healthcare compliance. Here at OSR, our goal is to:
Bring innovation to a dormant industry
Build a reliable and dependable team of experts
Provide regulatory services and advice at the simple click of a button
Robert (Rob) Merrill, J.D.
Rob is the co-founder and Managing Partner here at OSR. He has extensive experience working with pharmaceutical, biotech, and medical technology companies. Rob specializes in assisting with global risk assessments, independent reviews, and ethics and compliance program development. A representative sample of his experience includes developing global compliance programs for:
- Promotional compliance
- Sales and marketing practices
- Fraud and abuse laws
- State laws
- Sample compliance
- Compliance training
- Compliance monitoring and auditing
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Rob has significant industry experience in the areas of healthcare compliance, regulatory affairs, and risk management. Past positions include Compliance Officer and Senior Director of Regulatory Affairs. Rob received his Bachelor of Science degree in Biology from Utah State University and his Juris Doctorate (J.D.) from The John Marshall Law School in Chicago, Illinois.
Tracy Rockney, J.D.
Tracy Rockney 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 is extensive, including:
- Vice President of Regulatory Affairs, Global Labeling, Advertising & Promotion, and Regulatory Policy & Intelligence at AbbVie (formerly Abbott Pharmaceuticals)
- Senior Director of Global Regulatory Affairs at Shire Pharmaceuticals
- Director of Regulatory Affairs at Wyeth
- Director of Global Regulatory Strategy at Pfizer
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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.
Tracy received her Bachelor of Arts from the University at Albany, State University of New York, Rockefeller College of Public Affairs and Policy, and she earned her Juris Doctorate (J.D.) from Washburn University School of Law.