As we close the year, we were happy to have so many people join us for our much-anticipated cell and gene pipeline webinar.
On this significant day, November 27, 2023, I find myself thinking about our slow and steady (emphasis on slow) march toward DSCSA compliance over the past 10 years. Introduced to serialization in 2015 as an LSS Black Belt at a
If you haven’t had a chance to watch the on-demand webinar, “Navigating Drug Price Transparency: New Product Launch, Enforcement & Compliance,” but are curious about how DPT laws impact new product launches, we’re going to give you a
In recent blogs, we’ve covered the fundamental launch basics, plus all the other pieces that need to be prioritized when putting together a new product launch plan.
We’ve earned these insights from supporting more than 280 launches in 20 years.
In addition to the three most important elements in any launch, there are a lot more moving pieces to keep track of when you’re putting together your first product launch.
Consider this blog as your starting point checklist to
A lot of work goes into getting a new pharma product across the finish line, especially if you’re an emerging manufacturer launching your first product.
Every element of a launch strategy is important, but certain components outweigh others.
FDA Special Designations and Programs for Pipeline Drugs: How They Impact Drug Development Deep Dive
Part 2 of 2: Special Designation Deep Dive
This is the second part of a two-part series from Two Labs Drug Pipeline Manager, Ryan Chandanais
In the first blog in this 2-part series, I provided an overview of FDA Special
Part 1 of 2: Special Designation Overview
This is the first part of a two-part series from Two Labs Drug Pipeline Manager, Ryan Chandanais
The FDA has several special designations or programs to facilitate the development of drugs treating
If you haven’t already heard, Two Labs is talking a lot about patient services this year.
After spending six months on an objective study to assess the key attributes of patient services programs – and identify the companies that are
This blog is the second part of a two-part series from Two Labs Director of Serialization, Michael Rowe.
Check out the first blog for an introductory dive into what the new DSCSA tracing requirements are.