As organizations move closer to a commercial launch date, it is critical to understand the importance of distribution strategies, commercial compliance, and the various Federal and State programs that could have a major impact on pricing, transparency, government reporting requirements, and related systems and infrastructure.
“CIS offers a comprehensive service-based model that enables a small or virtual organization to have the same resources and commercial opportunities as a large or mid-size biopharmaceutical,” said Chris Cobourn, Senior Vice President, Commercial Compliance at CIS. “Simply stated, in the same way that many emerging pharmaceutical companies use a Third-Party Logistics Provider (3PL) for logistics and distribution, they use CIS as their back office team for commercial contracting and Government Programs operational support, as well as expertise in developing their commercial compliance program.”
CIS combines proprietary systems, proven methodologies, analytical skills, staff augmentation, and industry expertise to provide an outsourced commercial solution. The CGAP solution supports the client from early stage commercial strategies and pricing analysis to building a corporate compliance infrastructure, and completely managing commercial contracts and Federal and State regulated activities like Medicare and Medicaid and Aggregate Spend.
Cobourn adds, “Many of our clients do not have the in-house knowledge and expertise necessary to manage strategic contracts, develop a corporate compliance infrastructure, and oversee heavily-regulated programs, as well as Federal and State reporting requirements. The staffing and systems required for back office support can be significant, and the subject matter expertise to navigate the complex Federal and State requirements is difficult to find. CIS does more than explain critical laws and regulations; we take commercial contracting and compliance management off their plate as their Commercial and Government Accounts Partner.”
A case study outlining how CIS helped a virtual organization with their commercial requirements may be found at www.cis-partners.com/complianceservices/commercializationpartner.html. Visit CIS’ pharmacomplianceblog.com for a special three-part series focused on commercial contracting, compliance infrastructure, and Government Programs.
About Compliance Implementation Services (CIS)
Compliance Implementation Services (CIS) is a leading life sciences consulting firm specializing in compliance strategies for pharmaceutical, biotech, and medical device companies, from clinical, through manufacturing, commercial contracting, commercial compliance, and Government Programs.
CIS provides its clients with a deep understanding of industry laws and regulations, innovative and practical applications, and custom solutions to guide them to a better “Culture of Compliance” that is meaningful and sustainable. For more information, visit www.cis-partners.com.
