We assist clients market their products in ways that minimize any potential disruptions by regulators. We assist clients with:
- Developing the elements of a quality system, including procedures for compliance with Good Manufacturing Practice (GMP) regulations
- Providing standard operating procedures and developing effective complaint handling systems, including provisions for failure investigation
- Implementing procedures to comply with food, drug, and device reporting regulations
- Institutionalizing effective document change control
- Handling labeling and promotional issues, including "off label" nutritional, organic, and generic uses
- Gaining the support of professional society meetings
- Developing advertising and promotion materials, and managing their associated costs
- Managing interactions and promotions involving licensed health care professionals