Prescription Drugs and Biologics
OTC Drugs and Cosmetics
Medical Devices
Foods and Dietary Supplement
Health Care Fraud and Abuse
Enforcement and Compliance
Corporate Transactions
Advertising and Promotion
Tobacco
Product Jurisdiction and Combination Products
Child-Resistant packaging
Training Programs
Mediation and Arbitration Services


Marc Shapiro is an attorney focusing in the practice of food and drug law and related areas. With over 30 years of experience in private practice and as in-house counsel in a world-leading pharmaceutical company, as a past Chairman of the FDA Regulatory Law Focus Group of the Pharmaceutical Research and manufacturers Association (“PhRMA”) Law section, and as a former Senior Lecturing Fellow in food and drug law at Duke University School of Law, Mr. Shapiro is one of the country’s most knowledgeable and experienced practitioners of food and drug law.

He provides advice and counsel on a variety of FDA and related legal matters to life-science companies throughout the United States, including North Carolina, where he resides and practices. As described in more detail in SERVICES, this includes advice and counsel on matters pertaining to prescription drugs and biologics, OTC drugs and cosmetics, foods and dietary supplements, tobacco, healthcare fraud and abuse laws, compliance and enforcement, corporate transactions, and child-resist packaging laws and regulations.

Mr. Shapiro is available to speak on, or offer training in, a variety of subjects and topics of interest in food and drug law related matters.

Mr. Shapiro is also a certified North Carolina Superior Court mediator and is available to provide mediation services to help resolve business and commercial disputes without having to resort to litigation or to conduct mediated settlement conferences in the state and Federal courts in North Carolina.

Over 30 years of legal experience representing clients in private and in-house practice

ATTORNEY PROFILE

    • Over 30 years of legal experience representing clients in private and in-house practice
    • Certified North Carolina Superior Court Mediator
    • Senior Lecturing Fellow, Duke University School of Law for academic years 2000-2002
    • Former Primary Counsel to Glaxo Wellcome Research and Development
    • Chairman of the FDA Regulatory Law Focus Group of the Pharmaceutical Research and Manufacturers Association (“PhRMA) Law Section, May,1999 to March, 2001.
    • J.D., University of Virginia School of Law, Charlottesville, Virginia
    • B.A., University of North Carolina, Chapel Hill, North Carolina, Phi Beta Kappa