Licensing is a required step in the pharma industry, and unfortunately, it can be incredibly complicated. The consequences for not carrying the correct license can range from fines to an immediate stop in sales to felony charges – and that’s just the beginning.
We covered the basics in an earlier post, but while a general knowledge of the ins and outs is helpful, you’ll need more than an overview to navigate the various license types, regulations and state-specific laws.
Thankfully, you don’t have to handle it all on your own. A trade commercialization team can help you avoid detrimental licensing mistakes and set your company up for success from the start. Some of the benefits a trade partner can bring to the table include:
An ear to the (ever-changing) ground.
State licensing requirements change a lot and they vary from state to state. To make things harder, there’s no formal voting or amendment process to declare these changes and no central “hub” where you can see all updates from each state. It’s easy to miss an important change if you’re tackling licensing on your own, and unfortunately, the state boards don’t accept “I didn’t know” as an excuse.
But that’s where your consulting partner comes in. It’s their job to stay on top of all the changes and keep you informed of the ones that will – and might – affect you.
At Two Labs, our PharmaLicense team works with these state boards on a routine basis and track all license requirement updates. We’ve built relationships with key players in the industry to make sure we never miss a change.
Deep industry knowledge.
Even after you’ve managed to successfully get your initial licenses, there are a lot of outside factors that can affect compliance throughout the life of your company. Some are unexpected (see above), but your license can be impacted due to known, consistent factors as well. For example, if your company moves, gets acquired, goes public or goes through a host of other changes, you’ll need to reevaluate your compliance and update your license ASAP.
Again, not all states are the same, and what works for some doesn’t necessarily translate to others. To make the process smoother, you’ll need a partner with a far-reaching knowledge of all regulations and industry quirks. The right trade partner will not only understand the requirements for your state, but for all states. And they’ll understand the licensing ins and outs for your company in its current form, and as it evolves.
Big picture strategy.
Obtaining your state licenses is only one step in the process of launching your product. Looking at it in a silo can cause problems for your distribution down the road. Instead, a trade commercialization partner can look at your licensing as part of the larger whole, develop a strategy that gets it approved on time and make sure it aligns with your overall launch plan.
At Two Labs, we understand how to bring a product to market, and use that industry knowledge to guide our licensing strategies. We have the tools to help you before and after licensing, and can flag opportunities for your company as we work through the process.
For many companies, licensing tends to be an afterthought, but it can delay a launch or stop shipment all together. Instead of risking it, let us help! Our PharmaLicense experts are ready to dive into your overall commercial launch plan and get hands on with licensing. Below is a link you can click on to schedule time with James, one of our PharmaLicense experts!