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