I provide a creative, cost-effective, and above all, practical, "real world" solution to  clients' needs, based upon experience as a partner in a leading food and drug law firm representing a diverse group of brand-name and generic companies in the pharmaceutical, medical device, bulk chemical, cosmetic, nutraceutical and natural products fields, and as Division Counsel of a major multi-national pharmaceutical company. We appreciate the importance of providing practical assistance and being available to answer questions by telephone and e-mail which are knowledgeable, focused, succinct, creative, and expeditious.

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Broad expertise  

• Agencies: FDA, FTC, DEA, OIG, State Boards of Pharmacy, state and federal court litigation in FDA and related matters: drugs, devices, cosmetics, dietary supplements

• Enforcement actions, OAI, Warning Letters, litigation, agency and legal investigations, consent decrees, cGMP compliance

• Drug, device applications: counseling, strategizing, submission of 510K's, approvals

• Counseling and representation: FDA Regulatory, compliance, corporate governance, personnel and employment, litigation, trademarks

• Review of marketing, advertising, and promotion of pharmaceutical and medical devices; serve on company Promotional Review Committees (PRC)

• Agreements: research and manufacturing, product and technology licensing, joint ventures, commercial and corporate

• "General counsel" to smaller companies, extensive contacts in the food and drug field, including pharmaceutical companies, FDA, and the private bar

• "Of Counsel" FDA regulatory to two law firms; collaboration with multi-national law firms, ensuring broad support for any type of issue