About Compliance Implementation Services (CIS)

The Pharma Compliance Exchange (PCX) was developed and is maintained by Compliance Implementation Services, LLC ("CIS").

CIS, headquartered in the suburbs of Philadelphia, Pennsylvania, is a professional service company that focuses exclusively on providing compliance solutions to the pharmaceutical industry. CIS was co-founded by two industry experts who have spent the majority of their careers in pharmaceutical compliance and global operations.

CIS works with its clients to achieve compliance with applicable laws and regulations and improve or sustain operational performance. CIS offers a wide array of compliance management services in the areas of:

• The Medicaid Drug Rebate Program Reporting requirements
• The Veterans Healthcare Act
• The Medicare Modernization Act
• The Office of Inspector General (OIG) Compliance
• The Prescription Drug Marketing Act (PDMA)
• The Anti-Kickback Statute
• State and Federal False Claims Acts
• The Federal Sentencing Guidelines
• Sales/marketing compliance with FDA regulations and the PhRMA Code and OIG Guidelines
• Prevention of “marketing the spread” AWP-related behavior
• Current Good Manufacturing Practice (GMP)
• Current Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)

CIS’ professional staff offers extensive industry-specific regulatory knowledge combined with expertise in process design, mapping, documentation and training. CIS partners with its clients to develop, implement, and sustain regulatory compliance strategies best suited for their organizations’ cultures. Our expert teams have the regulatory, operational, legal and financial experience required to create efficient and effective compliance programs.

CIS provides knowledge on all available industry guidance, emerging regulatory trends and the complex compliance issues facing pharmaceutical companies in today's highly regulated and competitive environment.