Timely state licensing is just as critical as the FDA approval process
- Data & Documentation Submission
- Progress Tracking
- Management of Closing Process
When it comes 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) to carry a license, some states require:
- Your CMOs to carry a license
- A background check from your officers
- 3PL partners to be named on the application
- FDA approval
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 drug in that state.
Ultimately, this could mean:
- Lost opportunity
- Lost revenue
- Punitive fines from state boards of pharmacy
How We Can Help with State Licensing
At Two Labs, we guide all stakeholders in the supply chain through the state licensing process quickly and accurately. We work with:
- Rx Manufacturers (self and virtual)
- Medical Device Manufacturers
- OTC Manufacturers
- 3PLs
- Wholesalers
- CMOs
We have managed state licensing for over 100 new drugs, from startup companies launching their first product to larger global organizations that want to outsource the management of existing licenses.
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.