Bringing a new cancer drug to market and maintaining the quality of pet food. Both face complex regulations. We can quote them.
Arent Fox has one of the most comprehensive food and drug regulatory teams in the US, offering the full range of services that manufacturers and distributors of food, dietary supplements, pharmaceuticals, biologics, medical devices, cosmetics, and chemical products need to be successful in the market.
We counsel clients on product development and approval; development, implementation, and compliance with government inspections; food safety, labeling, and advertising requirements; product recalls; and regulatory and criminal investigations; as well as compliance with federal bioterrorism laws and other laws and regulations affecting the global marketing of food, drugs, cosmetics, and medical devices.
We also conduct due diligence reviews for FDA-regulated companies engaged in mergers, acquisitions, licensing deals and related corporate transactions. Our experience dealing with FDA compliance and enforcement issues allows us to identify and evaluate the significance of regulatory issues that may affect the value of a proposed transaction. Our firm’s additional expertise in FDA-related fields, such as patent, trademark, environmental, advertising, and healthcare law allows us to ascertain regulatory compliance from several compliance and enforcement perspectives and to incorporate regulatory diligence findings into deal terms and negotiations.