Case Study: a pharmaceutical company delivers timely EMA safety responses with Certara

Delivering High-Quality, Timely Responses to EMA Safety Queries

A leading pharmaceutical company faced a significant regulatory challenge when the European Medicines Agency (EMA) issued eight complex safety queries, which required a comprehensive response within a strict three-week timeline. The client engaged Certara for support, needing to address the multifaceted clinical, safety, and regulatory components of the queries under immense time pressure.

Certara implemented a highly collaborative and structured solution, assigning three dedicated safety writers to work in parallel across different time zones. They expedited the process by conducting quality control and client reviews on a rolling basis and facilitating daily team calls to keep all tasks on track. This approach enabled Certara to deliver a high-quality, comprehensive response to the EMA on time. The successful outcome led to the client expressing their appreciation and subsequently engaging Certara for additional regulatory and safety support.