Strengthen and streamline regulatory compliance with Genpact Regulatory as a Service
Life sciences firms need digitally assisted regulatory systems that enhance decision-making, agility, and productivity while reducing risk.
Genpact Regulatory as a Service (GRaaS) addresses key regulatory affairs and compliance elements, from strategy and submissions to approvals and ongoing maintenance. We support product lifecycle management and end-to-end publishing, providing analytics across submission processes.
Manage renewals, changes, and reports with scalable, end-to-end lifecycle management services tailored to regulatory needs.
One of our customers accomplished
1,500+
submissions annually through lifecycle management solutions
GRaaS – a forward-looking solution for compliance challenges
GRaaS integrates regulatory expertise and digital solutions to help companies address compliance needs effectively.
Our global, regional, and local operating models improve productivity and encourage ongoing innovation. We use technologies and a suite of preconfigured modules to simplify the whole regulatory affairs value chain
Create value from our regulatory compliance solution and digital skills
Combine our services and technology for:
Speed to value: Lightning-fast setup of the full-service offering using cloud-based, preconfigured software
Limited up-front investment: The subscription model includes the risk information management (RIM) platform and other startup costs
Flexibility: Companies can scale up or down as their portfolios change
Continuous innovation: RIM functionality, advanced technology, and workflow improvements
Reduced risk: Enhanced controls and analytics
Case study: How our end-to-end solution supports compliance goals
We manage the product lifecycle for a top pharma firm, including over 1,500 annual submissions (renewals, bids, and more) and more than 5,000 approval submissions. We also manage labeling updates for 29 nations and more than 40 products.
And we reviewed over 15,000 licenses for chemistry, manufacturing, and controls compliance, formatted 30,000-plus documents, and remedied more than 40,000 records to meet Identification of Medicinal Products standards.
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