BRAND MANUFACTURERS
State and Federal Pharmaceutical LicensingComplying with pharmaceutical licensing laws and regulations is not for the faint of heart. We make sure your company comes out the other side intact.
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.
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Checklist of key requirements for securing licenses.
Licensing starts with securing your home state license. You will need to pull together detailed information on your business, owners, officers, and key executives. Although information required will vary depending upon the specific state licenses you require, we’ve developed several tools to help streamline the process. For an overview of what you can expect click here:
Time needed to complete state licensing.
If you do not have an uncommon business model and are able to collect required information and materials without having to create content, you can expect most states will require three to four months of processing time. Some outliers can take much longer, often beyond 12 months: California, Florida, Maine, North Carolina, South Carolina, Nevada, and Tennessee are good examples.
California and Florida require Designated Representative Licenses as well. For these states, someone from your organization will be required to complete an online training program. Florida requires in-person testing.
How Prescription Analytics supports licensing initiatives.
To support your licensing initiatives, we begin with a full assessment of your specific licensing needs based upon your unique business model. Next, we:
Provide a full plan and budget based upon this assessment and have a robust toolset to capture the large amount of your data required to secure state and federal licenses.
Coordinate and manage the entire process for you and third parties that will need to be involved to ensure you are fully compliant with state and federal regulations.
Routinely monitor and report on existing licenses to ensure compliance even as state requirements shift or changes occur with your business. This is critical, as even simple data like officer or address changes require licensing updates.
Learn About Our Other Brand Services.
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