Select a Region North America

Case Study: FDA Inspection Win For a Mid-Sized Pharma Company with More Than 40+ Products in the USA and Outside the USA

the situation

The Situation

  • EVERSANA was approached to provide pharmacovigilance services to one of the largest generic manufacturers and distributors to support their U.S. and Ex-U.S. post marketed products (more than 40 products). Their product portfolio was very extensive and had the potential to continue to grow.
  • The client needed a pharmacovigilance service provider who can support all products for end-to-end pharmacovigilance services including REMS, audit and inspection support.
the solution

The Solution

  • Data Migration of legacy data: EVERSANA developed a data migration plan to handle the legacy data.
  • Implementation of End-to-end PV Services: A Safety Management Plan was developed outlining the roles and responsibilities to cover the post marketing reporting of the individual cases and aggregate reports.
  • We provided ICSR, literature and aggregate services.
  • REMS program: EVERSANA, on behalf of the client, also managed their REMS program. EVERSANA’s responsibilities expanded over the period to include signal detection and medical writing (health hazard assessments and medical evaluation).
  • Audit and Inspection: EVERSANA supported the client during an FDA inspection.
the results

The Results

  • Successful implementation and continuation of services for more than 5 years with EVERSANA.
  • Referral of EVERSANA’s services to other companies.
  • Successful FDA inspection outcome with no findings.