BROOMFIELD, Colo., USA – (28 January 2020) – Global content intelligence solutions leader, Amplexor, and Genpact (NYSE: G), a global professional services firm focused on delivering digital transformation, today announced that they are forming a strategic alliance where Genpact will provide enhanced Digital Transformation services to support Amplexor’s Regulatory Information Management (RIM) solution.
Amplexor is a recognized expert in the field of RIM - its holistic end-to-end regulatory solutions marketed globally for more than 10 years and used by Fortune 500 Life Sciences companies. Regulatory affairs departments, executive management, and other stakeholders rely on Amplexor’s Life Sciences Suite to deliver a complete, real-time overview of regulatory information, submission management and publishing and full post-approval lifecycle management. With the announcement of the Genpact alliance, the Amplexor RIM expertise will be packaged with and integrated into Genpact’s regulatory processes to provide the most comprehensive regulatory service capability in the market today.
Genpact is a global professional services firm focused on delivering digital transformation via automation and robust data management services supporting Regulatory Operations. Genpact is one of the first service providers to complete an end-to-end automation assessment for a Top Pharma company that included review of ~90 sub-processes within Regulatory Operations, Labeling and CMC functions. In addition, Genpact’s data management practice utilizes a comprehensive methodology consisting of tools, processes, best practices, and resources to ensure clients’ data is complete, consistent, and accurate throughout the product lifecycle. Whether it is steady state, in advance of a technology implementation project (such as RIM or master data management), or a full digital transformation, ensuring quality data is critical.
As part of this partnership, Genpact is creating an integrated, end-to-end Regulatory as a Service (RaaS) offering, leveraging Amplexor’s RIM solution. The new service will blend Genpact’s strengths in regulatory product lifecycle management with Amplexor’s unified and holistic RIM solution, enabling Life Sciences companies to take advantage of an unrivalled, end-to-end proposition with full business process support.
“Life Sciences organizations are increasingly seeking one supplier to provide an integrated, seamless, effective and efficient regulatory service, backed up by a leading regulatory solution, to manage the lifecycle of their products. This alliance brings together our respective expertise for one service offering that will work on top of the most advanced holistic RIM solution,” comments Elvis Paćelat, Executive Vice President, Life Sciences, Amplexor. “With looming obligations, such as IDMP coming into force, now is the right time to look at a smarter, more efficient and more cost-effective way of ensuring regulatory compliance.”
“At Genpact, we are always keen to partner with fellow experts in order to offer our customers a more blended range of services,” adds Rajiv Naidu, Regulatory Affairs Service Line Leader, Genpact. “Amplexor complements our regulatory expertise with its RIM solutions and enables us to offer enhanced Digital Transformation services, giving our life sciences clients the depth of services, they need to meet growing regulatory and compliance demands.”
Amplexor and Genpact will host a webinar this Wednesday, 29 January 2020 that will provide an in-depth review of the Regulatory-as-a-Service offering, part of the broader data management collaboration. To register please click here.