- EVERSANA was approached to provide pharmacovigilance services to a small-sized pharma company with generic products and a portfolio in the U.S. and Europe (5 products with 2 combination products).
- The client needed a service provider who understands the granularity of complex regulatory requirements for their combination products and delivers end-to-end PV services.
- 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.
- Combination Product Configuration in the Safety Database: Client was onboarded into safety database with all detailed configurations that are required for submission as per Regulatory requirements.
- Strategic Advice on Quality Management System: Strategic advice to the client, review of their internal SOPs and procedures to ensure regulatory compliance to combination requirements.
- Aggregate Reports: EVERSANA also developed a customized PADER template for these products to accommodate the sections specific for the device reports for these products.
- Established PV system catering to all combination products for ICSR and aggregate reports.
- The client continues to work with EVERSANA and has been extremely satisfied with the services.
- The client has been 100% compliant with regulatory requirements and has initiated discussion about their other portfolio for services.