Pharmacovigilance and Safety Surveillance for Pre-Approval and Marketed Health Products

Delivering safety surveillance before and after regulatory approval

Veristat has expanded its pre-approval and post-marketing pharmacovigilance and safety monitoring support with the acquisition of Certus PV.    The combination creates a unique and unrivaled team of safety and pharmacovigilance experts who offer pre-approval support for drug developers working to get therapies approved and post-marketing support for marketing authorization holders/applicants to keep their products on the market.

Demonstrating patient safety throughout the entire product development lifecycle requires years of experience, expertise with regulatory agency interactions, and a proven history of success.

Ensuring Drug Safety Across All Phases of Development and Post-Approval  

While it is critical to ensure patient safety throughout clinical trial planning, execution, and the regulatory approval process, it doesn’t end there. Once a therapeutic receives regulatory approval, long-term safety monitoring begins to ensure continued patient safety.

We can help you develop, negotiate, and implement your Risk Management Plans with the regulatory agencies. The process begins during the preparation of the marketing application (e.g., NDA, NDS, BLA, etc.) and continues post-approval for the entire time the product/therapeutic is on the market.