Introduction
Several factors are responsible for the significant changes in the regulatory operations landscape throughout the past few decades: 1. the evolution of certain regulatory requirements (e.g., eCTD, xEVMPD); 2. the rising burden of lifecycle management in the face of shrinking budgets; and 3. cloud-native and digital technologies that have transformed the regulatory process and streamlined operations.
Despite the progress made, regulatory functions are still struggling to achieve excellence and realize the full benefits from these multi-year, multi-million dollar transformations. In this paper, Syneos Health’s Caroline Masterman-Smith (Business Analyst, R&D IT) and Aatif Kababi (Engagement Manager, R&D) discuss and recommend solutions that companies can harness for success.
