Traditional regulatory systems, often built in silos, are struggling to keep up with global regulatory demands, product complexity, and ever-evolving standards. Enter the new paradigm: Connected, Composable, and Cognitive regulatory platforms-a trio of capabilities that is reshaping how life sciences companies approach regulatory operations.
Regulatory professionals in life sciences know the stakes are high. According to a recent report, life sciences companies spend an average of 30% of their time just managing regulatory submissions and ensuring compliance. As the pressure mounts, organizations need a solution that not only keeps pace with this growing demand but also enables greater efficiency, accuracy, and scalability.
How many hours have you spent chasing submission deadlines, tracking label changes across markets, or wrestling with disconnected regulatory systems?
If you’re like most regulatory professionals in the life sciences industry, the answer is probably “too many.” The regulatory landscape has grown increasingly complex-faster global rollouts, more stringent compliance requirements, and an ever-growing web of region-specific regulations. And yet, many teams are still relying on fragmented tools and outdated workflows that slow them down and increase the risk of errors.
Regulatory work isn’t slow because it has to be, it’s slow because it’s fragmented. Generative AI is stepping in to change that. Embedded in Unified RIMS platforms, GenAI is rewriting the rules of regulatory operations. It drafts documents, anticipates compliance risks, tracks global regulation shifts, and helps teams move faster without sacrificing accuracy. What once took weeks can now take hours, with better results.
Disconnected systems, fragmented data, and manual regulatory workflows are still the norm for many life sciences companies-and they’re silently costing time, compliance, and market opportunities. As submission volumes increase and global regulatory expectations become more stringent, these inefficiencies are no longer sustainable.
This is why Unified Regulatory Information Management Systems (RIMS)-especially those powered by AI-are no longer optional. They are critical.