Distribution & Licensing

Distribution licensing is the final, critical step in the process of getting drugs and medical devices to market.

But navigating the route is daunting. We get you there. PorzioCS and Porzio Distribution Licensing helps life sciences companies handle all aspects of state licensing for the distribution of pharmaceutical products and medical devices. We understand the smallest nuances of the complex licensing process, from initial licenses to renewals and reportable changes.

We help clients by:

  • Identifying Relevant State Licensing Requirements: We identify all applicable requirements and prepare, review, and file applications through all licensing bodies.
  • Tailoring Applications to Distribution Models: Whether manufacturer or distributor, handling product or virtual, we ensure that the right applications are filed in the required jurisdictions.
  • Preparing for Compliance: We prepare our customers for compliance by advising on all requisites and prerequisites, including bonding, fingerprinting and background checks, licenses to do business, testing of designated personnel, and preparing for a state inspection.

Our team has decades of experience providing highly accurate, responsive service on all licensing issues for drugs and medical devices. Licensing is our exclusive focus, but we do more than fill out licensing forms. As a subsidiary of Porzio, Bromberg & Newman, P.C., a leading life sciences law firm, we have an understanding of the broader compliance picture that allows us to spot issues that others can’t.We help clients that range in size from global pharmaceutical companies to newly launched start-ups. Porzio Distribution Licensing regularly assists:

  • Drug and device manufacturers
  • Virtual manufacturers
  • Distribution centers
  • Third-party logistics providers
  • Wholesale distributors
  • DME providers
4,000+
initial licenses secured
160
licensing customers
50
number of states with licenses secured
Expertise
in Pharma, Med Device, Wholesale, and 3PL
Access
to Regulatory Updates
Real-World Solutions from Porzio Compliance Services
PorzioCS specializes in assisting emerging pharmaceutical, biotech, and medtech companies in preparing for product launches upon approval. Our team collaborates with company representatives across legal, regulatory, supply chain, and commercial operations to gather the necessary information and documents for state license applications. Beyond this, PorzioCS offers valuable consultation on critical timelines, including contracting with third-party logistics providers, ensuring designated representative qualifications, engaging registered agents, meeting surety bond requirements, and fulfilling state inspection prerequisites. This comprehensive approach ensures that complete applications are submitted in a timely manner, allowing for a seamless and planned product launch.
PorzioCS has been engaged by large pharmaceutical companies and corporate law firms as consultants in multimillion-dollar mergers and acquisitions. Our team assists in mapping out and managing state licensing issues, ensuring that the target or surviving company can continue to operate post-close. PorzioCS provides critical information regarding timing and prerequisites in advance of contracting, enabling corporate attorneys to structure deals that assure a smooth transition. Additionally, PorzioCS has extensive experience working with major companies to navigate the requirements and unique challenges of spinning off business units into separate independent entities. Whether it's an internal reorganization, a change of address, or a multimillion-dollar deal, PorzioCS is dedicated to ensuring continuity of supply.
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Our team monitors jurisdictional requirements and changes to licensure forms and helps companies who are adding locations or chancing officers, which are just two of the many circumstances that mandate license amendments. Under the leadership of Porzio Distribution Licensing head Frank Fazio, our management team has been intact for more than a decade.

Frank Fazio, RPH, JD
Senior Vice President, Distribution & Licensing Services
[email protected]
(973) 889-4202

Have a question?
Contact Porzio Distribution Licensing
to find out more about our licensing solutions.
Porzio Distribution Licensing is a service of Porzio Compliance Services.