Rolling out a new pharmaceutical product is an exciting milestone, but it comes with significant regulatory and operational challenges. For manufacturers required to meet reporting obligations under CMS, Price Transparency laws, and other government pricing programs, having a structured approach is critical to ensure compliance and avoid costly pitfalls.
This is where our Launch Assurance Checklist comes in. Designed specifically for pharmaceutical companies, this checklist provides a step-by-step roadmap to guide you through the complexities of launching a new drug. From pre-launch preparations to post-launch reporting, it ensures that every requirement is addressed efficiently and accurately.
Why You Need This Checklist
- Streamlined Compliance: Regulatory requirements can be overwhelming, especially for new products. This checklist helps you stay organized and ensures you meet all deadlines for CMS reporting, Price Transparency laws, and government pricing calculations.
- Improved Operational Efficiency: By breaking down tasks into manageable steps with clear timelines, the checklist reduces the risk of errors and last-minute scrambles.
- Risk Mitigation: Missing key reporting deadlines or failing to validate product information can lead to penalties or delays. This checklist minimizes those risks by providing a clear framework for action.
- Comprehensive Coverage: Whether it’s loading product data into reporting systems or conducting price adjustments post-launch, the checklist covers every critical task.
Key Tasks in the Checklist
Here’s an overview of what the checklist includes:
- 120 Days Prior to Launch:
- Gather and validate product information for CMS and Price Transparency requirements.
- Cross-check data with the FDA product database.
- 90–120 Days Prior to Launch:
- Conduct price modeling to assess WAC (Wholesale Acquisition Cost) impact.
- Load validated product information into Government Pricing and Price Transparency Reporting systems to determine where you have to report and when.
- 60 Days Prior to Launch:
- Submit reports for states requiring Price Transparency Reporting.
- Post-Launch Tasks:
- Load new products into Medicaid Drug Programs (MDP), ASP portal, and HRSA OPAIS quarterly.
- Certify products in MDP, HRSA, and ASP portals.
- Send product pricing to your third-party logistics (3PL) provider for distribution,, or distribute directly to customers if you do not utilize a 3PL.
- Conduct Public Health Service (PHS) price adjustments following initial quarterly government pricing calculations.
How This Checklist Helps You Succeed
This checklist isn’t just about ticking boxes; it’s about creating a seamless process that allows you to focus on delivering value to patients while maintaining compliance. By following these steps, your team will be equipped to confidently handle the complexities of launching a new drug. Download it now!
Our team of experts is here to support you every step of the way. With decades of experience in pharmaceutical compliance and regulatory requirements, we understand the complexities of launching a new drug and meeting stringent reporting obligations. From gathering and validating product information to navigating post-launch price adjustments, we provide tailored solutions to ensure you stay compliant and avoid costly pitfalls.
Let us help you streamline your processes, mitigate risks, and focus on what matters most—delivering value to patients. Ready to get started? Contact us today to set up a preliminary call with our team. We’ll work with you to hash out your needs, address your challenges, and develop a customized plan to guide you through every stage of the process.