This department manages some of the industry’s most high-risk areas. Our team understands that commercial initiatives are often critical for success, but the monitoring and oversight process can be difficult in practice.
Our team has experience developing real-world solutions that ensure commercial initiatives remain legally compliant while still allowing business operations to run smoothly. From speaker programs to product samples, this department is tasked with some of the most complicated to manage programs offered. Indeed, speaker programs are among the most heavily scrutinized activities by government entities today. By their very nature, speaker programs require manufacturers to contract with and compensate various healthcare professionals to deliver these programs. Similarly, under the Prescription Drug Marketing Act (PDMA), pharmaceutical manufacturers must ensure that they have policies and procedures in place – that are being followed – to manage compliance requirements. The PDMA contains stringent regulations to ensure the proper use and distribution of pharmaceutical samples and to combat drug diversion.