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Each state has imposed its own independent reporting requirements on manufacturers
States have developed State Drug Price Transparency (DPT) legislation in response to the increasing pressure for greater price transparency within the US. Navigating this highly dynamic and evolving regulatory landscape of DPT requires a dedicated effort due to its ever-changing nature.
State Drug Price Transparency includes requirements prior to FDA approval and launch. Not only is receiving a PDUFA date from the FDA an essential step in launching your product, but the clock on reporting also begins the day your PDUFA date is received. All drug manufacturers have some sort of price reporting obligation, even if no pricing action is taken on the products.
At Two Labs, we oversee hundreds of state submissions for 40+ clients every year, maintaining their DPT compliance by assisting with quarterly and annual standard reporting, and providing ongoing support.
You will have the support of a dedicated account manager on your account with support from Subject Matter Experts.
Our in-house regulatory analysts will proactively monitor the ever-changing regulatory landscape and legislation for you.
You will have access to our cloud-based content repository for all key documents, including SOP, reports submitted to the state, and evidence of state receipt of submission.
You will have assistance with ongoing reporting triggered by requirements, and we monitor upcoming reporting deadlines, assist with submissions, confirmations, and much more.
We handle the entire process for our clients, including filling out and submitting reports and changes to the states to meet reporting requirements, saving them time and money. Two Labs serves as your long-term strategic partner to maintain DPT compliance and avoid fines through any report triggering events, including price increases, new product launches, new drug applications, and fixed ongoing dates.
Reporting obligations follow a product through its entire lifecycle
Each state has imposed its own independent reporting requirements on manufacturers
States have developed State Drug Price Transparency (DPT) legislation in response to the increasing pressure for greater price transparency within the US. Navigating this highly dynamic and evolving regulatory landscape of DPT requires a dedicated effort due to its ever-changing nature.
State Drug Price Transparency includes requirements prior to FDA approval and launch. Not only is receiving a PDUFA date from the FDA an essential step in launching your product, but the clock on reporting also begins the day your PDUFA date is received. All drug manufacturers have some sort of price reporting obligation, even if no pricing action is taken on the products.
At Two Labs, we oversee hundreds of state submissions for 40+ clients every year, maintaining their DPT compliance by assisting with quarterly and annual standard reporting, and providing ongoing support.
You will have the support of a dedicated account manager on your account with support from Subject Matter Experts.
Our in-house regulatory analysts will proactively monitor the ever-changing regulatory landscape and legislation for you.
You will have access to our cloud-based content repository for all key documents, including SOP, reports submitted to the state, and evidence of state receipt of submission.
You will have assistance with ongoing reporting triggered by requirements, and we monitor upcoming reporting deadlines, assist with submissions, confirmations, and much more.
We handle the entire process for our clients, including filling out and submitting reports and changes to the states to meet reporting requirements, saving them time and money. Two Labs serves as your long-term strategic partner to maintain DPT compliance and avoid fines through any report triggering events, including price increases, new product launches, new drug applications, and fixed ongoing dates.
No matter where you are in the process, we’re here to support, advise, and implement key strategies to ensure the success of your product.
Through every step of the commercial journey, Two Labs is your partner in driving success.
110 Riverbend Avenue, Suite 100
Powell, OH 43065
Phone: (614) 389-4004
Fax: (866) 259-4324
Email: info@twolabs.com
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