Benjamin E. James

• Advised foreign drug manufacturers regarding FDA facility inspections and resulting corrective/preventive actions.
• Conducted FDA and health care due diligence for a major pharmaceutical company in advance of a potential merger.
• Advised a foreign drug manufacturer on compliance with the U.S. Drug Supply Chain Security Act (DSCSA).
• Counseled Fortune 500 companies on domestic and international regulatory compliance matters, including FDA and EU requirements for pharmaceutical products and food contact materials.
• Obtained Food Contact Notifications for food contact materials including coatings, plastic additives, and polymers.
• Assessed chemistry and toxicity data on food contact chemicals to ensure safety and compliance with regulatory standards.

Benjamin E. James advises pharmaceutical and medical device companies on a variety of regulatory matters, including Current Good Manufacturing Practices (CGMP) for drug manufacturing, Food and Drug Administration (FDA) inspections of manufacturing facilities, and corporate transactions involving life sciences companies. Benjamin also advises clients on safety assessments, drug supply chain issues, and risk management related to drug products.

Outside of the pharmaceutical space, Benjamin serves the food contact materials industry by helping companies obtain premarket clearances from global regulatory authorities. These include Food Contact Notifications (FCNs) from the FDA, and listings on the European Union’s Plastics Regulation, Commission Regulation (EU) No 10/2011.

Benjamin gained experience as a legal intern for the Office of the County Attorney in Montgomery County, MD. He was also a fellow for The American Constitution Society for Law and Policy. He earned his J.D. from the American University Washington College of Law, cum laude, where he served as a senior staff member of the American University International Law Review.

Bar Admissions

• District of Columbia

Education

• American University (J.D., 2021)
• University of Michigan (B.A., 2017)