Biopharma Compliance Services

Compliance

Access the deep expertise and white-glove support you need
to navigate biopharma product compliance

About

Compliance

Positioning biopharma products for market success

Beyond the logistical questions of how you will distribute your product and coordinate a new product launch, you also have to ensure your company and drug are compliant with various state government entities and visible to all payers and prescribers.

At  Two Labs, we have helped launch over 280 new biopharma products. We know what it takes to ensure your compliance and visibility are not roadblocks but instead differentiators for how your product is perceived by physicians, payers, patients, and other stakeholders. We provide the guidance and hands-on support your team needs to focus on what they do best: improving patients’ lives.

Featured Services

State Licensing

Each state has different licensing requirements and states make frequent changes to their rules and guidelines, making it difficult to manage and maintain compliance. Our job is to keep track of each and every state’s changing laws to make sure that all of our clients are properly licensed in each of them. A dedicated account manager handles the entire process for our clients, from building a compliance strategy that is specific to your company and distribution model, to managing the application process with the state agencies.

State Drug Price Transparency

Meeting your reporting obligations in every state is especially challenging in a legislative landscape that is always evolving. At Two Labs, our team has helped dozens of clients with hundreds of state submissions quarterly, annually, and when changes in product or pricing required it. We also proactively monitor changes in legislation across the country in order to keep you up to date and on schedule.

Compendia

Payers, government entities, EHRs, Pharmacies all rely on your product’s compendia data. If data is missing or incorrect, it can cause a myriad of problems. Our goal is not only to make sure this doesn’t happen but also to use your compendia listing as a way to clinically differentiate your product.

EHRx Solutions​

Even if your drug is approved and ready to be sold, it doesn’t mean that Prescribers will be able to find it. With over 700+ Electronic Health Records (EHRs) on the market, ensuring HCP and Prescriber visibility is a critical component to launching your product successfully. We take a proactive and reactive approach so your product gets correctly listed in EHRs on the front end while also quickly resolving any visibility issues that arise when your sales team is talking to HCPs.

Sunshine Transparency & Aggregate Spend

Under the US Physician Payments Sunshine Act of 2013, now referred to as Open Payments, drug and medical device manufacturers are required to annually report payments and transfers of value to HCPs and HCOs. Since then, the spend transparency landscape has continued to grow in scale and complexity, including unique requirements on a state-by-state basis. At Two Labs, we simplify transparency reporting by gathering the right expenses, aggregating and remediating data, and preparing and submitting reports.

Meet Your Team of Experts

Our experts are the reason 90% of our clients would recommend Two Labs to a colleague.

Ryan Fields

Senior Vice President, Compliance

With 20+ years of experience in pharmaceutical and medical device distribution, Ryan is an expert at helping pharma manufacturers navigate the complex landscapes of compendia databases, e-prescribing platforms, and state regulatory licensing and compliance requirements. With over 280+ new product launches, including retail and specialty, his team is committed to helping clients ensure compliance and visibility for their companies and products in order to help patients lead a better life.

Alisha Nielsen

Vice President, Compendia

Andy Parks

Vice President, Compliance

Leah Boose

Director, State Drug Price Transparency

Crystal Nielsen

Director, Compendia and EHRx Services

Carley Kelly

Sr. Director of State Licensing at Two Labs

What can we help you with today?

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.

5 Ways Compendia Impacts Your Business

Most manufacturers consider Compendia “price books,” but while pricing is part of Compendia, it’s actually just a small component. Much of the information coming from Compendia is clinical and has an impact on every part of the product decision making process.

Learn More >

Launch Fundamentals: State Licensing

Did you know that 7 states require FDA approval before issuing a license? Download our free Launch Fundamentals ebook, State Licensing: Avoiding Launch Delays with a Comprehensive State Licensing Strategy, to learn more.

3PL Case Study

Compliance Insights

Want to dig a little deeper into what Compliance can do for you? Here are just a few examples of how we make a difference for our clients.

We’re here to support your success from clinical to commercial – and beyond.

How can we help you today?