Marketing FDA-Approved Products
We want to help you market your products in ways that minimize any potential disruptions by regulators. Our FDA Regulatory attorneys can help you with developing the elements of a quality system, including procedures for compliance with current Good Manufacturing Practice (GMP) regulations. We can work with you to develop standard operating procedures and develop effective complaint handling systems, including provisions for failure investigation. We can help you implement procedures to comply with food and beverage, drug, and device reporting regulations, as well as institutionalize effective document change control. Our attorneys also are experienced in handling labeling and promotional issues, including “off-label” nutritional, organic, and generic uses.
Our product marketing services are not limited to internal corporate procedures. In addition to working with you to develop advertising and promotion materials and manage their associated costs, we can help you gain the support of professional society meetings.