Licensing 2017-09-05T11:08:09+00:00

Licensing

We clear state licensing hurdles

Timely state licensing is just as critical as your FDA approval process. It can profoundly impact your entire product launch — from setup with distribution partners to your sales and production forecasts.

Two Labs’ PharmaLicense services provide extensive experience to guide you through the state licensing process quickly and accurately.

We have managed all types of licensing engagements, from startup companies launching their first product to larger global organizations that want to outsource management of existing licenses:

  • Brand, generic, OTC and medical device manufacturers
  • Virtual pharmaceutical manufacturers
  • Third-party logistics providers
  • Wholesalers
  • Self-distributors
  • Controlled substance manufacturers
  • Foreign entities

Clearing regulatory hurdles is essential to a successful pharma product launch. Our comprehensive, hands-on approach to state licensing allows you to focus on other aspects of your launch and product portfolio.

We manage the complexities of initial licensing and required annual renewal licensing—plus provide strategy and due diligence for acquisition and licensure gaps.

We streamline the licensing process, ensure accuracy and complete applications, and provide complete transparency with Two Labs’ proprietary, interactive, web-based software. We will:

  • Submit all required data and documentation via a secure, easy-to-use online portal
  • Track progress with real-time status updates for each state application
  • Manage the closing process, including signatures and notarization

Our PharmaLicense services constantly monitor state licensing requirements, from changes to state forms to new legislation.

We conduct a biannual survey of all 50 states to ensure continued compliance, immediately communicating any changes to you via our dedicated account manager assigned to your project.

Pharma licensing requirements vary from state to state. Several states, for example, require:

  • Licenses from your CMO
  • A background check on your officers
  • Registered agents
  • Your 3PL to be named in the application

Partner with us to launch your pharmaceutical product.

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