Staying current with ever-changing laws and regulations is a critical compliance concern that applies equally to pharmaceutical and medical device commercialization efforts.
No matter the product or disease state, size of the sales team, or the channels utilized, healthcare commercialization must comply with numerous laws and regulations. From accurate aggregate spend reporting (Sunshine Act) to protecting patient information (HIPAA/HITECH) to following the False Claims Act and Anti-Kickback Statute requirements, pharmaceutical sales strategies must be built on a foundation of compliance, and keep current with ever-changing health care trends, guidelines, laws, and government regulations.
PDI’s compliance services can help you design policies that ensure your full compliance with government regulations.
We recognize that compliance risk cannot be outsourced. Our approach is custom designed to your specific needs.
PDI employs a fulltime dedicated compliance department with 30 years of healthcare industry experience. Our compliance department provides oversight, guidance and monitoring for all employees engaged in HCP interactions on your behalf, ensuring compliance with key regulatory guidelines.
We will collaborate with your organization’s established compliance department to ensure seamless execution of your program. For emerging organizations, we can design and implement an effective compliance for your PDI team as well as your home office.
Our compliance services include:
- Drafting of compliance standard operating procedures and code of conduct
- Effective and entertaining learning content and delivery
- Development of auditing and monitoring work plans and corrective actions
- CIA risk mitigation – including escalation processes
- Aggregate spend documentation and tracking
- Regulatory credentialing (e.g. Chicago and Washington D.C.)
- Sample distribution and support
Whether you need an extension of your well-established approach or need someone to assist in the design and implementation of your program, PDI Compliance can be your answer.