Laws and regulations that govern the manufacture, distribution and dispensing of prescription pharmaceuticals extend beyond the federal government. Every state and U.S. territory has its own complex and unique regulatory authority. If you’re not familiar with the landscape, complying with licensing laws is challenging.
We manage the complexity, workload, process duration and ever-shifting list of requirements involved in state and federal pharmaceutical licensing. Supporting and guiding you through the process, we mitigate the risk of costly mistakes.
Your business model drives the type and number of licenses required.
Let’s say you’re contracting with a 3PL to warehouse, as well as pick, pack and ship. You may be able to leverage the licenses of your 3PL in some states. Or, if you are making use of a Title Model where another entity is purchasing your product, taking title, and shipping the product into various states, it is likely you won’t require many individual state licenses.
Your approach should take into account various trade-offs driven by quality, timing, geographic nuance and financial impact. Prescription Analytics can help you assess your situation. We also recommend that you make your legal counsel an integral part of the process.