Two Labs

Navigating compliance in the pharmaceutical industry can be challenging, especially for emerging manufacturers. That's why we’ve created an all-inclusive eBook to help you master the essentials— aggregate spend, drug price transparency, and government price reporting—all in one place! Whether you're preparing for a product launch or enhancing your compliance strategy, our guide will equip you with actionable steps and insights to: > Streamline reporting processes > Stay ahead of state and federal regulations > Avoid penalties and safeguard your business > Build a foundation of transparency and ethical practices Download the eBook now! https://bit.ly/3Lchsyab

At the Alliance for Regenerative Medicine's #CellandGene Meeting on the Mesa, we’re diving deep into the complexities of launching cell and gene therapies. Our very own Kyle Felmet, VP of Specialty Commercialization will lead the panel, "Anatomy of a CGT Launch: Operationalizing Cell and Gene Therapy." Join us to gain actionable insights from industry experts on making your next CGT launch a success. Don't miss this opportunity to learn from the best in the business! #CellandGeneTherapy #CGTLaunch #TwoLabs

With the pharmaceutical industry racing towards full DSCSA compliance this November, the FDA and industry stakeholders are taking significant steps to secure the drug supply chain. A key development in this effort is the enhanced CDER NextGen Portal—a powerful tool designed to streamline critical communications and improve process efficiency. Our latest blog, Tatiana Salvano, explores how this portal supports: - FDA 3911 submissions - Suspect drug investigations - Waiver Exception & Exemption (WEE) submissions Discover the benefits, challenges, and whether this tool is the right fit for your organization here: https://bit.ly/4dRARkv 

Hello from Washington, D.C.! Michael Rowe, Greg Makin, Tatiana Salvano, and Amanda Addezio are excited to be at the 2024 Healthcare Distribution Alliance Traceability Seminar! Stop by Booth 20 to chat with our team about how Two Labs can support your traceability and compliance needs. Let’s discuss how we can help safeguard your supply chain and ensure you’re ready for the future of pharmaceutical compliance.

Happy International Dog Day!🐾 What better way to celebrate this day than giving a nod to the “two labs” who inspired our name - Hunter and Barnaby! These two pups have been at the heart of our story, symbolizing the loyalty and dedication we bring to our work every day. Join us in celebrating all the furry friends who bring joy to our lives.

Michael Rowe, Greg Makin, Tatiana Salvano, & Amanda Addezio are heading to the 2024 HDA - Healthcare Distribution Alliance Traceability Seminar in Washington, D.C., next week! Visit them at Booth 20 to learn how our innovative solutions can help you stay ahead of compliance challenges and secure the integrity of your drug supply chain.

Compliance in the pharmaceutical and medical device industries requires a strategic approach to HCP and HCO spending disclosures. Chapter 5 of our latest ebook, "Clarity in Compliance," focuses on three essential steps to ensure your reporting is thorough and accurate: - Identify Reportable Activities with Precision: It’s not always obvious which vendor activities need to be reported. Learn how to systematically identify all potentially reportable interactions, reducing your risk of missing crucial data. - Conduct Comprehensive Spend Inventory Assessments: Beyond the basics—uncover hidden reportable expenditures through detailed assessments. Understand the full scope of your financial interactions and ensure no transfer of value is overlooked. - Develop Robust Reporting Documentation: Create clear, detailed documentation to avoid inconsistencies and errors. From methodology to playbooks, build a solid foundation for ongoing, accurate compliance reporting. Download the full eBook to dive deeper into these strategies and streamline your compliance processes:  https://bit.ly/3Lchsya

Navigating the complex world of pharmaceutical compliance isn't just about staying on the right side of the law—it's about safeguarding your company’s future. Chapter 4 of our eBook, "Clarity in Compliance," dives deep into the penalties associated with non-compliance in government price reporting and drug price transparency. Whether it's hefty fines, civil and criminal judgments, or even suspension from federal programs, the risks are real and significant. This chapter outlines critical actions to help avoid these pitfalls, ensuring your data submissions are accurate and timely. Download our ebook today:  https://bit.ly/3Lchsya

“I like to say that there's a breadcrumb of serialized data that moves with the product as it moves, as it changes hands, and as a way for companies to have their own database to use in a suspect drug investigation to help identify counterfeits.” In the second video of his interview series, Michael Rowe dives into the importance of serialized data in the pharmaceutical supply chain, highlighting how each breadcrumb of data ensures the safety and integrity of medications. Whether you're in manufacturing, distribution, or pharmacy operations, understanding these nuances is essential for maintaining compliance and protecting patient safety. Check out his full interview below!

Michael Rowe, Senior Director of DSCSA/Serialization Compliance Services, was recently interviewed by Pharmaceutical Commerce Magazine for an in-depth video series on the Drug Supply Chain Security Act (DSCSA). In this first video, he breaks down the DSCSA's inception, its milestones, and how it has revolutionized the pharmaceutical industry by standardizing the track-and-trace of prescription drugs in the U.S. Check out his interview below and stay tuned for more!