In the Pharmaceutical industry, licensing is never a static process. There are many changes that can alter your licensing strategy:
1. Your Company
This one is pretty obvious. There are a number of different business changes that could direct the strategy of your licensing, or the maintenance of your state licenses. Some of the most common occurrences are: a change of business entity (i.e. LLC to INC), a change of officers, or moving. These are the more common instances, but there is a wide variety of scenarios that may affect your company’s licensing strategy. Remember, each state interprets business changes differently according to its own statutes.
Are you making any strategic business changes? Fill out this form and let us check to see if it will affect your Licensing.
2. Contract Manufacturing Organization (CMO)
If your CMO moves, it might affect your state licensing more than you would expect. States are now asking for your CMO’s license number on applications, and to provide a copy of the FDA’s inspection report. If any pharmaceutical manufacturer opens a new facility, they have to go through the rigmarole of an FDA inspection all over again to get an updated license. This can adversely impact your licensing if the required states aren’t updated with the change.
3. Third-Party Logistics Provider (3PL)
Similar to the CMO, if a 3PL changes locations or opens up a new location, this may alter your state licensing. The states vary on the requirement of a 3PL’s license: several states allow a company to piggyback off of its 3PL’s license, a handful require your 3PL’s state license to be listed, and a few print the 3PL’s location on your license. In each scenario, your 3PL’s business activities may adversely change your state licensing strategy and the process of maintaining your state licensing.
If any of these situations sounds like something your company is faced with now or potentially in the future, contact the Two Labs PharmaLicense team and let us determine if your future plans will alter your licensing strategy.