Currently, most companies are not conducting impact analyses from a proactive point of view, which would help them to anticipate an issue or even make good commercial decisions ahead of the competition. All too often, knowledge remains siloed. What is needed rather is to turn that information into strategic corporate knowledge. This would require a change in internal processes, cross-functional communication from a regulatory intelligence perspective, and a dedicated knowledge management solution to determine the value of the insights gathered.
That’s where Celegence’s Simplified Regulatory Intelligence (SRI) platform makes the difference for regulatory intelligence functions.
For example, an internal team might carry out an impact assessment on a regulatory change in a specific market or filter for specific information to guide strategy when launching a product into a new market. Once carried out, the team would need a central place to store their analyses so that other functions can assess their own level of involvement for any required changes or actions. The regulatory intelligence team will also want to analyze multiple sources of data, including agency websites, conferences and forums, trade associations, analyst insights such as intelligence compiled by research groups, as well as other regulatory intelligence services.
Sifting through all this information, deciphering it, and organizing it into digestible components for the right people is complex and time consuming. The SRI platform has a defined data structure for storing regulatory intelligence which helps organizations stay ahead of mandatory requirements worldwide. For example, if there’s a change, the solution can specify which process area or part of the business is affected — such as the publishing and submission, manufacturing, or labelling – and what action is required. The relevant business units are then sent an impact assessment, so they are able to take quick action.
As the need for impactful and targeted regulatory intelligence becomes more and more pressing for the Life Sciences industry, it won’t be enough to simply gather data. The ability to filter and digest it will become a greater priority. And that’s the missing piece of the puzzle that our Simplified Regulatory Intelligence System fills for the industry.