Case Study: RIMS & xEVMPD for Global Pharmaceutical Company
A global biopharmaceutical company needed to streamline operations for its regulatory affairs activities, including xEVMPD submissions, document formatting, publishing and submissions to health authorities, and RIMS data collection and management.
Celegence Solution & Approach:
To achieve these objectives, the company turned to Celegence as an extension of its own internal regulatory affairs team to manage the following:
Through its CoE working model, Celegence has delivered measurable improvements and outcomes to the biopharma client. These include:
Key to the success of the partnership was the time committed to understanding the client’s goals and objectives through detailed workshops. This helped to set the tone for the project and ensure quality outcomes from the delivery team. Furthermore, having a common understanding of requirements resulted in faster turnaround time and zero errors.