Case Study: FDA Inspection Win For a Mid-Sized Pharma Company with More Than 40+ Products in the USA and Outside the USA
The Situation
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.
The Solution
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.
The Results
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.
