Timely state licensing is just a critical as the FDA approval process
When it come to State Licensing, each state has different requirements
State licensing can be a complicated process, largely because each state decides the rules for themselves and there are constant changes and updates that aren’t easy to keep track of or even find.
For instance, as a prerequisite for you (as the NDA/BLA holder or a medical device company) to carry a license, some states require:
It’s a lot of information to stay updated on, but if manufacturers get anything wrong on their applications, that means they won’t be able to sell their product in that state.
Ultimately, this could mean:
At Two Labs, we guide all stakeholders in the supply chain through the state licensing process quickly and accurately. We work with:
We have managed state licensing for 100+ products. Our clients range from startups launching their first product to global organizations outsourcing the management of existing licenses, including medical device manufacturers whose on-market products now face new licensing requirements.
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. To stay on top of changes, we conduct a biannual survey of all 50 states to ensure continued compliance, immediately communicating any changes to you via our dedicated account manager assigned to your project.
But we also handle the entire process for our clients, including filling out and submitting applications, meaning the process is extremely easy on them and their teams and when it comes time to launch your product you don’t face any avoidable obstacles.
After the initial licensing we continue as your long-term strategic partner, advising through events like M&A, portfolio expansion and corporate structure changes just to name a few, so you don’t face any avoidable obstacles.
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.
