Commercial Operations

Your employees are expected to meet the highest of ethical standards as well as legal and regulatory requirements. Achieving compliance with the U.S. healthcare laws and the rules that govern your employees’ interactions with customers and medical professionals can be complex, and oftentimes the applicable guidance is vague. CIS provides tailored program development for pharmaceutical sales and marketing activities to meet the standards set by:

  • The Federal Anti-kickback Law
  • The Federal False Claims Act
  • The Medicaid “Best Price” Law
  • The PhRMA Code on Interactions with Healthcare Professionals
  • FDA Laws and Regulations
  • Federal Privacy Laws
  • State Anti-kickback, Privacy and Consumer Protection Laws
  • Safe Harbors

CIS helps clients maintain a competitive advantage while meeting regulatory requirements and adhering to applicable guidance through thoughtful development of programs in the areas of:

  • Product Pricing and Promotion
  • Sample Management
  • Grants and CME support
  • Promotional Speaker Programs
  • Charitable Donations
  • Local Exhibits, Trade Shows & Displays
  • Patient Assistance Programs
  • Preceptor Programs
  • Phase IV Activities