- 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.
- 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.
- 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.