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Case Study: FDA Inspection Win for Mid-Sized Pharma (50+ Products) with Extensive Generic Product Portfolio

the situation

The Situation

  • EVERSANA was approached by a mid-sized pharma company with more than 50 generic products and portfolio in the U.S. to provide pharmacovigilance services.
  • The client needed a service provider who is a partner and not just vendor to handle their end-to-end PV services.
the solution

The Solution

  • 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.
  • Training on all Products: Client required all training to be conducted and documented, which was done prior to launch and on time.
  • SDEA: The client had agreements for data exchange for different products with their Partners, EVERSANA worked with the client to understand the safety data exchange between the client and their Partners.
  • Strategic Advice on Quality Management System: Strategic advice to the client, review of their internal SOPs and procedures and the agreements between the client and their Partners
  • FDA Inspection Support: EVERSANA also played a crucial role by providing immense support to the client at the time of FDA inspection.
the results

The Results

  • Established PV system catering to all products for ICSR, aggregate and literature reviews for 50+ products.
  • The client continues to work with EVERSANA and has been extremely satisfied with the services.
  • The client also expressed their interest in providing their Clinical trial drug safety services to EVERSANA in the future.