Frier Levitt provides unique legal advice and counseling to pharmaceutical manufacturers and repackagers in a variety of contexts. Frier Levitt has represented repackagers of bulk active pharmaceutical ingredients (APIs) in a variety of matters ranging from importing of goods to contract negotiation. Frier Levitt has also provided advice and assistance to manufacturers of FDA-approved finished drugs. Through these representative matters, Frier Levitt has gained unique insight and experience in advising manufacturers and repackagers as they navigate the maze of applicable laws and regulations. Perhaps most importantly, Frier Levitt can provide a complete representation of manufacturers and repackagers in all areas including transactional services, corporate structuring, regulatory practice, litigation services, and intellectual property.
In representing manufacturers and repackagers, Frier Levitt attorneys rely upon the multitude of Federal and State laws and regulations, including insurance regulations, State Pharmacy Practice Acts, FDA rules and regulations, the Drug Quality and Security Act, DEA rules and regulations, State controlled substances laws and regulations, ERISA laws and regulations, Anti-Kickback Statute, Stark Law, False Claims Act, Tricare rules and regulations, Medicare/CMS rules and regulations, Medicaid rules and regulations, FTC rules and regulations, and the Lanham Act.
In addition, our attorneys have experience in representing our clients before a variety of Federal agencies, including the Department of Justice, the Department of Defense, the Office of Inspector General, the Food and Drug Administration, the Federal Trade Commission, and various State Offices of Medicaid Inspector General.
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