Regulatory Compliance

We advise companies on compliance with Food and Drug Administration (FDA) regulations, guidance, policies, and procedures regarding drugs, food, and cosmetics. Our compliance counseling experience spans a broad range of contexts including:

• Development of effective compliance programs for pharmaceutical manufacturers, including standard operating procedures (SOPs), employee codes of conduct, internal investigations, and self-reporting;
• Informed consent, institutional review board (IRB) approval, and clinical trial registration and reporting;
• Pharmaceutical and food advertising and promotion;
• Change reporting and supplemental application requirements for drugs;
• OTC monograph requirements for drug product formulation and labeling;
• Product safety monitoring and adverse event reporting;
• Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP);
• Product formulation, labeling, and claims including permissible product ingredients, health claims, nutrient content, and “structure/function” claims for foods;
• Food Safety Modernization Act compliance, involving hazard analysis, preventive control and corrective action plans, supplier verification programs, track-and-trace, and recordkeeping requirements; and
• Import and export requirements, international trade (customs and country-of-origin matters, European Union (EU) regulation and policies).

Contact Us

Tracy Heinzman
202.719.7106 | theinzman@wiley.law

David B. Weinberg
202.719.7102 | dweinberg@wiley.law