Helping Clients Achieve Cost-Effective Compliance

Our practice delivers effective results for our clients through a combination of experience and creative problem solving strategies. We handle a full array of FDA, Customs, USDA, and related regulatory agency matters. The expertise of our FDA lawyers and attorneys extends to:

• Foods;
• Medical devices;
• Pharmaceuticals;
• OTC drugs;
• Biologics;
• Biotechnology;
• Animal feeds and drugs;
• Cosmetics;
• Electronic radiation products;
• Consumer products.

We assist our clients in responding to FDA 483s, warning letters, injunctions, prosecutions, detentions, refusal, Customs penalties and import aaclerts.

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.

Our FDA lawyers 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.