Celegence Deploys Centre of Excellence Model to Streamline Regulatory Activities

Project Summary

A global biopharmaceutical company headquartered in France wanted 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.

 

To achieve these objectives, the company needed to overcome several challenges. First, its limited internal resources were required to manage regulatory, pharmacovigilance and medical affairs activities. A second big issue was that of consistency, both in terms of RIMS data and in terms of MS-Word templates for dossier submissions. A third big challenge for the company was addressing the competing priorities between regulatory data management and regulatory operations in terms of pre-submission, submission and post-submission activities.

Celegence Solution & Approach:

The biopharma client chose Celegence and its Center of Excellence (CoE) working model was contracted to act as an extended arm of its internal regulatory affairs team. The use of the CoE model allowed for integrated teams to be built, creating synergies between various regulatory activities. The Celegence team first sought to understand the current processes through multiple workshops on the different operational areas. The workshop helped the team to develop an analysis of current vs. desired outcomes and processes. Discussion focused on Standard Operating Procedures (SOPs), Work Instructions (WI), and IT tools for performing activities related to various processes as well as roles and responsibilities of the resources. This analysis helped to identify gaps in each area and to establish the optimized processes, tools and roles. Subsequently, a proof-of-concept was conducted for each process area to evaluate the effectiveness of the newly enhanced processes.

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