Problems We Solve: Compliance with Changing Laws

The regulatory requirements for foods, drugs, cosmetics, devices, and tobacco products are frequently changing as Congress passes new laws (such as the Food Safety Modernization Action (FSMA) and the Drug Supply Chain Security Act (DQSA)). Furthermore, FDA implements new regulations (such as the Foreign Supplier Verification Program (FSVP) and Hazard Analysis and Risk-based Preventive Control (HARPC)), updates previous regulations (such as nutrition labeling), and updates guidance documents on a regular basis. We understand these changes and work with our clients to explain how these changing requirements influence their business operations. We make recommendations on how to comply with the changes while minimizing the impact on their business operations.