GTN & Commercial Strategy and Operations

Gross-to-Net and Commercial Strategy and Operations

Federal Compliance Solutions (FCS) provides end-to-end Gross-to-Net (GTN) support for emerging, mid-sized, and large life science companies, supporting clients with best-in-class people, processes, and data management. We align all key Gross-to-Net stakeholders within the organization who manage the GTN process, including finance, revenue accounting, market access, trade, and commercial operations. This enables organizations to have one source of truth with GTN forecasts.

Our team of finance and accounting experts specialize in life sciences. We have deep expertise in the complexities of the regulatory environment and the commercial marketplace in the United States, as well as the impact on GTN. We are committed to staying on top of key commercial market and regulatory issues, such as the impacts of the drug provisions in the 2022 Inflation Reduction Act. We support clients in evaluating the impact of regulation such as IRA on contracting strategies, allowing our clients to respond to an evolving pricing and contracting environment with a focus on forecast accuracy and profitability.

FCS helps our clients set up leading practices as it pertains to the Gross-to-Net process. This encompasses data management from the transactional data acquired from customers across the distribution and payer landscape, roles and responsibilities within the organization, methodologies for forecasting and accruals, and evaluating deal profitability across key pre-deal and post-deal analytics.

How We Help

Today’s complex business landscape requires companies to effectively capture critical information, validate data, and manage it from the bottom up to anticipate forecast changes and avoid costly surprises. FCS provides the critical processes you can trust to grow and scale your business. We provide bottom-up forecasting models that allow manufacturers to accurately forecast their business from a financial close support perspective and gain a clear picture of business evolution across payers and channel discounts to evaluate both profitability and progress. We support our clients in accrual management and balance sheet reconciliation on a monthly and quarterly basis to ensure the reasonableness of balance sheet reserves and maintain accurate and well-controlled financial reporting.

Our Gross-to-Net and Commercial Strategy and Operations services include:

• GTN Process Evaluation and Design
• GTN Data Management
• Contract Master Management 
• Forecasting and Long Range Planning
• Revenue Financial Close Management
• Monthly Accruals and Balance Sheet Reconciliation 
• Scenario Modeling, including Pre-Deal and Post-Deal Analytics
• Modeling the Impact of Government Regulation on GTN, including Inflation Reduction Act, AMP Cap Removal, and Medicare Part B Discarded Drug Units
• Ongoing GTN Financial Close Support