Improve regulatory compliance and drive transformation with regulatory as a service

With stricter regulatory controls from global health authorities, life sciences companies are working with knowledgeable teams to put intelligent, digitally assisted regulatory systems in place to gain valuable operational insights. This will help them make their workforces, processes, and technology more efficient, as well as bolster decision-making, agility, and productivity while reducing risk. Genpact regulatory as a service (GRaaS) is a comprehensive innovative solution, covering every aspect of regulatory affairs and compliance from strategy to submissions and approvals, and post-approval maintenance.

GRaaS – a pioneering approach to compliance demands

What makes GRaaS such a robust solution is our strategic alliance with recognized experts in regulatory information management (RIM). Our GRaaS offering combines the expertise of long-standing regulatory specialists in the field with the right mix of digital solutions. This twofold approach helps companies unleash hidden business potential while easing and virtually eliminating the constant compliance burdens their workers must address. Our global, regional, and local operating models help optimize costs, boost productivity, and make innovations and improvements an ongoing reality. And we deploy basic technologies, such as robotic process automation (RPA) and assisted bots, as part of our service, too. Our strategic partnerships provide a superior life sciences suite of preconfigured modules set to digitally simplify the entire regulatory affairs value chain and get to work quickly with both infrastructure and cloud-based software.

GRaaS is also structured on a spectrum, from modular to full service. Clients can opt for:

• Product lifecycle management as a service – Regulatory project management and end-to-end scalable post-approval processes including renewals, product changes, and annual reports
• Publishing as a service – An agile, scalable, and best-in-class technological infrastructure that plans, manages, dispatches, tracks, and archives final submissions
• Certificate of pharmaceutical product (CPP) submission content as a service – Provides real-time analytics to keep stakeholders informed at every stage of CPP processing

Bundling services and technology together in this manner gives you standardized and repeatable best-in-class processes, superb services, and cutting-edge digital solutions. Here's what you get:

• Speed to value – Setup of the full service offering, using cloud-based preconfigured software, is lightning fast
• Limited upfront investment – The subscription model incorporates the RIM platform and other startup costs
• Flexibility and agility – Clients can scale up and down as needed or as portfolios change
• Continuous innovation – The solution delivers RIM platform functionality, RPA deployment, and workflow improvements
• Reduced risk –Lean Six Sigma-engineered processes ensure enhanced controls and analytics

Complying with ever-more stringent regulations is no longer a chore. With GRaaS, the process is simplified, standardized, streamlined, and efficient. Just as importantly, its combined service and technology offer an added benefit. It can deliver the new business insights and novel ways of operating that today's companies need to stay ahead of the game.

An end-to end service that drives transformation and improves compliance

We've provided end-to-end product lifecycle management for one of the top five pharmaceutical companies in the form of more than 1,500 submissions annually covering renewals, bids, and more. We also tendered more than 5,000 submissions for approval, coordinated labeling updates for 29 countries and more than 40 products, and reviewed more than 15,000 licenses to ensure chemistry, manufacturing, and controls (CMC) compliance. In addition, we've formatted more than 30,000 documents and remediated more than 40,000 records to meet Identification of Medicinal Products (IDMP) standards. For the submission and approval process, we offer end-to-end managed services across product lifecycles using our global regulatory professionals and local experts.