Peter O. Safir

Peter O. Safir serves as a Professorial Lecturer in Law at George Washington University Law School since 1991 while concurrently practicing as a food and drug regulatory partner at Covington & Burling with nearly 30 years of industry experience. He is widely recognized as a leading authority in pharmaceutical regulatory law and represents major clients in complex compliance matters.

His educational background includes:

• BA from Princeton University
• JD from Yale University

Mr. Safir specializes in Food and Drug Regulation with deep expertise in pharmaceutical marketing practices, life cycle management, drug quality systems, and manufacturing compliance. His professional focus encompasses:

• Medical device regulatory frameworks
• PhRMA Code implementation and enforcement
• Federal/State Anti-Kickback statute compliance
• Fraud and abuse investigations
• Good Manufacturing Practice (GMP) enforcement defense
• Hatch-Waxman litigation strategy

He has published extensively on drug regulation and frequently serves as an expert witness in regulatory disputes, though no specific scientific awards are documented. Professionally, he advised PhRMA in drafting the industry code and guides major pharmaceutical companies through complex compliance challenges, but academic student advising details are not provided. No laboratory affiliations or research teams are mentioned in available materials.