Case Study: Successful Implementation of End-To-End Pharmacovigilance Services For Drug-Device Combination Product Portfolio
The Situation
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.
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.
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.
The Results
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.
