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Hyman, Phelps & McNamara has its finger on the pulse of the FDA and extensive experience with the universe of issues faced by companies regulated by FDA. As the largest dedicated FDA law firm in the United States, our technical expertise and industry knowledge are exceptionally wide and deep. Our nuanced understanding of the FDA's inner workings helps you: - Create efficient and effective strategies for premarket submissions and product approval
- Develop and execute regulatory and product lifecycle management strategies
- Establish and maintain high-quality, compliant processes and procedures for manufacturing, storage, and distribution
- Market compliant products
- Successfully promote products while meeting regulatory obligations
- Conduct internal audits and investigations
- Respond to government inspections and investigations
- Assess compliance and other regulatory issues (due diligence) for mergers and acquisitions.
From legal challenges based on science to marketing to controlled substances regulation, our legal team stays with your product through every challenge. Indeed, no legal team handles a broader range of food, drug, and medical device issues. We counsel businesses throughout the supply chain and their management, scientists, marketers, and compliance officers on issues involving the following agencies in addition to FDA: - Drug Enforcement Administration (DEA)
- Centers for Medicare & Medicaid Services (CMS)
- Federal Trade Commission (FTC)
- Consumer Product Safety Commission (CPSC)
- U.S. Department of Agriculture (USDA)
Our strong industry experience enables us to understand your problems and offer practical legal solutions in the context of your business.
- Smart and committed: We care about the issues you care about, and we devote our resources to finding answers to the questions that keep you up at night.
- Responsive: We pride ourselves on our rapid response to clients.
- Experienced: A proven legal expert will work directly with you. We have more than twice as many directors as associates; and even our most junior associates are devoted to our specialized practice areas.
- Client-focused: We focus on finding the best solutions for you. We’ll provide the legal team you need, no more and no less.
- Specialized: This may be your first time facing this issue, but chances are, it’s not ours.