RIM Accelerating Efficiencies in Regulatory Pathways

As drug development and market approval grow more connected and complex, effective regulatory information management (RIM) is more essential than ever. “The ideal state would be to leverage regulatory data as a corporate asset,” suggests Venkatraman “Bala” Balasubramanian, Senior Vice President of Life Sciences, Orion Business Innovation. “Regulatory teams will be able to better advise portfolio teams on probability of regulatory success in any given market, so you’re going to have higher success rates from a regulatory perspective going forward,” concurs Pat Shafer, Managing Director, FTI Consulting. Bala and Pat serve in the Working Group developing the Regulatory Information Management reference model discussed at DIA's 2020 Regulatory Submissions Information & Document Management Forum.