GENERIC MANUFACTURERS

State and Federal Pharmaceutical Licensing


The process of securing the pharmaceutical licenses you require can often feel overwhelming and unending. We provide relief.

What makes securing a pharmaceutical license difficult? The process is complex. It’s time-consuming. The list of requirements you have to meet changes regularly, forcing you to update your work. It can wear you out.

Federal laws are simpler in the sense that they are uniform. But state and territorial requirements governing the manufacturing and wholesale distribution of generic pharmaceuticals can vary widely and change regularly.

Our team serves as your strategic navigator. Our job is to manage the complexities. We help guide you through the process, mitigate the risk of costly mistakes, and ensure you secure licenses while remaining fully compliant.

Download a summary of our services for generic pharmaceutical manufacturers.

Services for Generic Manufacturers
How do you know which pharmaceutical licenses will be required?

The answer depends on your business model and location. If you are contracting with a 3PL, you may be able to avoid securing licenses in some states. That’s because the 3PL would be conducting product distribution for each state and relying on its own licenses.

Or, if another organization purchases your product, takes title, and ships into various states, it likely eliminates your need for many individual state licenses.

Our team can assess your situation and help you evaluate the trade-offs to determine your best approach. No matter what, we always recommend engaging legal counsel throughout the process.


How long does it take to get a state license?

Usually, it takes three to four months of processing time to get a state license. That’s if your business model is not uncommon and you can easily pull the necessary information and materials. In some states (California, Florida, Maine, North Carolina, Nevada, Tennessee and South Carolina), the process can extend beyond 12 months.

California and Florida also require Designated Representative Licenses and training. For a California license, someone from your company will need to complete online training. Florida requires in-person testing.

Key requirements for securing pharmaceutical licenses.

First, you will need to gather certain details about your business, ownership and executives and secure your home state pharmaceutical license. Securing your home state license is typically a basic requirement for you to do business and to secure licensure in other states. See our checklist of all that you can expect to encounter, depending upon the state licenses you intend to acquire.

Checklist for securing licenses

Bring the right partner on board.

If you choose to work with a strategic partner, look for their comprehensive set of licensing support services. Expect them to assess your specific licensing needs based upon your business model. We provide a full plan and budget based upon this assessment and have a robust toolset to capture the large amount of client data required to secure state and federal pharmaceutical licenses.

We coordinate and manage the entire process for our clients and the additional third parties that will need to be involved to ensure full compliance with state and federal regulations. We routinely monitor and report on existing licenses to ensure compliance even as state requirements shift or changes occur with a client’s business.

It is critically important that your strategic partner be agile. Even simple elements such as changes in officers or your address require licensing updates. Constant change is a certainty.

State and Federal Pharmaceutical Licensing