Genpact Regulatory Affairs enables clients to source scalable regulatory operations services, and transition to an operating model that meets their business needs:
Stage 1: IMPROVE the current regulatory operating model with a Genpact Regulatory Affairs regulatory solution that focuses on cost-effective regulatory services combined with process and technology tools to achieve incremental productivity improvements. With CMC services, this may focus on routine lifecycle management activities, such as variations, achieving efficiency improvements of 20-30%;
Stage 2: With a regulatory solution that consolidates operations across business divisions clients can TRANSFORM the operating model. CMC services in each business unit are transitioned to global hubs, which specialize and standardize operations, realizing 2-3x the efficiency benefits;
Stage 3: A strategic outsourcing partnership with Genpact Regulatory Affairs, where maintenance activities for a set of mature products are externalized, can SUSTAIN efficiency benefits of 3-10x.
Genpact Regulatory Affairs can lead clients at any stage through meaningful transformation, and tailor the service model to their unique business requirements. This includes technical staffing, project consulting, or sustainable, full-service outsourcing. Our industry experts can determine the solution that meets current operational needs, or support clients in evolving their operating model, leveraging the right mix of process, technology and analytics to achieve new levels of operational efficiency and performance.