The practice of C. Humphrey & Associates P.A., is one of only a few law firms in the United States that concentrates on FDA law, trade and regulatory compliance. We distinguish ourselves in our ability to handle the most complex legal matters, while providing clients with a close, personal service often nonexistent in larger firms. Our FDA lawyers and customs attorneys pride themselves on their flexibility, efficiency and responsiveness. Our team of FDA regulation and compliance attorneys can provide guidance on warning letter response, food labeling, product introduction and international trade. Our experience is impressive. We understand the regulatory process from all perspectives, and we harness this knowledge to the benefit of our international and domestic clientele.
Our practice handles a full array of FDA, customs, USDA, and related regulatory agency matters. Our expertise extends to foods, medical devices, pharmaceuticals, OTC drugs, biologics, biotechnology, animal feeds and drugs, cosmetics, and electronic radiation products, animal drugs and consumer products. Based in Miami and serving clients both domestic and international, we can assist your company in responding to FDA 483s, warning letters, injunctions, prosecutions, detentions, refusal, Customs penalties and import alerts. Our expertise on promotion and advertising, labeling issues, exports and imports, MDR reporting, QSR and GMP requirements, and other regulatory issues provides our clients with confidence and security that their products and processes are compliant in the most cost-effective manner available. We also prepare our clients for meetings with FDA personnel on compliance matters and represent clients before the Agency on enforcement, policy and rulemaking issues, and litigation.
