Regulatory Information Management (RIM) is one of the highest priority investment areas in Life Sciences R&D today, driven by the need to greatly improve the efficiency of regulatory globally, currently averaging 43% across 18 RIM capabilities[1], and manage regulatory information as a true enterprise asset. In this paper, we will examine why – even now – this RIM transformation narrative still remains all too familiar with discussions still focused on cloud vs on-premise, suites vs best of breed and capability-oriented discussions about documents, registrations, publishing, labelling and archiving. These feel like only incremental improvements from where we were 20+ years ago, where ICH standards work led to the standardization of e-submissions (eCTD) in many markets.
We contend the way we think about RIM is fundamentally outdated and is significantly damaging our ability to fully advance the Regulatory Affairs function. In this paper, we will examine a multitude of contributing factors and propose some new approaches, as the potential business benefit is significant! You may not agree with some of our points and that is fine, as our goal, first and foremost, is to stimulate the conversation to move Regulatory Affairs to the next level.
