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Case Study: EVERSANA’s Regulatory Consulting Saves Big for Virtual Manufacturer: Uncovers Non-Compliance, Excessive Costs, and Risks

the situation

The Situation

  • A mid-sized biopharmaceutical company utilized a well-established state licensing service provider for initial state licensing applications but was unhappy with their services.
  •  The biopharmaceutical company needed an accountable partner to monitor and maintain their state licenses. The Client was unsure that the licenses their current provider had acquired were all required and were unsure if they were missing some required licenses. Additionally, the Client’s Designated Representative (DR) had recently changed, and the Client was required to notify all states immediately.
the solution

The Solution

  • EVERSANA’s Regulatory Consulting completed a Regulatory Assessment of the Client’s business operations, products, and all 51 state regulations to confirm status as a Virtual Manufacturer and would be required to be licensed in 38 states.
  • With this knowledge, the Client was licensed in several states that they were not required to be licensed in; EVERSANA canceled those licenses.
  • The Client was not licensed in several states that they were required to be licensed in; EVERSANA applied for licensure in these states immediately.
  • EVERSANA’s Regulatory Consulting reported the Designated Representative change to all 38 states in accordance with their preferred means of notification.
  • Finally, EVERSANA performed regulatory monitoring of all states and managed all renewals for the Client.
the results

The Results

  • Regulatory Assessment for company and product specifics across 51 state regulations
  • Monthly Monitoring
  • License Renewals
  • Additional Initial Applications