Easing regulatory pressures for a global pharma

Life sciences companies around the world face an uphill battle with increasing work volumes, as legal requirements around drug approvals continue to evolve. To secure these all-important approvals, companies must be flexible enough to rapidly deploy significant resources. After drugs have been approved, maintaining licenses remains a challenge for many companies, forcing too many people to spend too much time on repetitive tasks, and hampering their ability to add value and contribute to growth.

In that context, our client began looking for a partner to lead a dramatic shift. The firm wanted to apply advanced thinking, new technology tools, and innovative design to transform all of these processes – and put growth at the forefront.

Plus, in looking for a partner, the client had other criteria in mind. We had to be able share risk while still maintaining our commitment to quality and compliance. At Genpact, we pride ourselves on our ability to increase visibility into operations, heighten spend intelligence, improve benchmarking, evangelize best practices, and ensure quality while driving compliance. By meeting these requirements, we felt confident we could scale operations for the client in a way that made processes far more agile.

Here's how our two-pronged approach worked:

Process

• Established centers of excellence (CoE) for submission management, authoring, translation management, publishing, and regional support for submission management and translations
• Introduced management and strategy policies for post-approval maintenance submissions
• As the company underwent digital transformation, we delivered effective operations and continuous improvement in outcomes with end-to-end process oversight
• Our master black belt Lean Six Sigma team drove process re-engineering

Innovation

• Set up a collaborative innovation team to foster fresh thinking and improve overall productivity in day-today operations
• Helped governance and operational teams develop an innovation platform that eased and quickened the route between ideas and implementation
• Identified and deployed digital technologies that increased automation and transformed workflows, improving quality and leading to faster delivery

Here's what the company gained by partnering with Genpact:

• Scalable regulatory resources thanks to a dedicated global team of some 150 regulatory professionals, all of them cross-trained and capable of flexing to meet the client's requirements
• Real performance insights made possible by analytics and executive-level dashboards across the processes
• Improved compliance and cycle time due to visibility of workflow and targeted continuous improvements, together with the standardization of key processes and communications
• Efficiency savings of more than 20% over a five-year period, plus more than 40 ideas implemented in the first 12 months
• Innovations in client operations aligned with Genpact Cora RegAssure – our regulatory product lifecycle management solution – including more than 10 high-impact joint innovation projects
• Elimination of siloed processes between submission coordinators, CMC, and publishing, enabling better control of the end to end processes
• Automation in planning and reporting, which resulted in a 5% productivity improvement in the renewals process in the first nine months alone

By partnering with Genpact, the company was able to embed new skills and drive behaviors that will allow it to flourish – and maintain compliance of existing products, while focusing on bringing new products to market even faster. That benefits the enterprise. It also benefits their patients.