The new solutions will support pharma manufacturers navigating new state requirements on drug reporting
COLUMBUS, Ohio, March 29, 2023 /PRNewswire/ -- Today, Two Labs, an industry-leading pharma services company, is officially unveiling its State Drug Price Transparency (DPT) managed service offerings to help emerging pharmaceutical manufacturers navigate the evolving regulatory landscape imposed by each state's own independent reporting requirements. After providing consultation on DPT to over 30 clients since 2021, Two Labs is now formally rolling out the new outsourced managed service offering to continue supporting clients with meeting requirement needs.
Each state has imposed its own independent reporting requirements on manufacturers, and the clock on reporting begins the day the PDUFA date is received from the FDA. State Drug Price Transparency has ongoing commercialized product specifications, regardless if any pricing action is taken on the products. Additionally, given the complexity, oftentimes, even modest price increases can trigger additional reporting. And, reporting obligations continue through the end of a product's lifecycle.
"As pharmaceutical regulatory requirements for disclosing drug prices continue to evolve on a state-by-state basis, proactively monitoring the landscape and supporting clients in this space is crucial," said Howard Miller, CEO of Two Labs. "Our team's deep expertise makes us poised to lead emerging pharmaceutical manufacturers through the journey of price reporting obligations and how to remain compliant as they distribute their products nationwide."
This new service is an expansion of Two Labs' established commercialization support. Two Labs' DPT team provides clients with a dedicated account manager and subject matter experts that can address state-specific concerns; in-house regulatory analysis and proactive monitoring of the ever-changing regulatory landscape, including changes to current requirements for manufacturers; and key documentation that includes reports submitted to the states and evidence of state receipt of submission.
"Our team already has a strong pulse on the landscape and with states ramping up on enforcement activity, we're able to provide a turnkey solution to partners navigating new requirements," said Andy Parks, Vice President of Compliance at Two Labs. "Working with a wide range of emerging drug manufacturers, we have a proven track record and extensive experience supporting partners with ongoing compliance needs."
More information about State Drug Price Transparency can be found here. For a free consultation, call us at 614-389-4004 or email [email protected].
About Two Labs
Two Labs is a leading pharmaceutical services company that partners with pharma/biotech companies, providing integrated and customized commercial solutions. We help chart the path from clinical to commercial for a new product launch and provide strategies for continued market viability for drugs on the market. Since its inception in 2003, Two Labs has led 280+ new product launches and more than 300+ in-market projects from pre-launch to loss of exclusivity. For more information, visit www.TwoLabs.com.
SOURCE Two Labs, LLC
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