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.