Consulting & Technology
Generating Regulatory Affairs Impact
Regulatory affairs organizations need global scale and flexibility to meet complex requirements - but regulatory management costs are under scrutiny.
Genpact Pharmalink helps organizations adopt a strategic approach that harnesses new regulatory operating models, technology, and data management to re-imagine their global regulatory affairs operations to create greater value for their businesses while keeping costs practical.
Genpact Pharmalink's unique Lean DigitalSM approach harnesses the power of process-centric digital technologies, design thinking methods, Lean principles and domain expertise to deliver a broad range of consulting and technology transformation services. Our solution portfolio includes the following:
Regulatory operating model assessment and strategic road map:
- To help companies transform to a target operating model, we assess their regulatory affairs operations and determine their effectiveness. From these insights, we develop a future vision, a road map, and a business case for change. This includes the identification of core vs. non-core activities, outsourcing readiness, as well as the transition execution to an outsourced operating model.
Technology strategies and roadmap:
- To achieve technological transformation, our subject matter experts partner with clients to develop the required strategies, road maps, and governance frameworks. Using leveraging digital tools, such as our digital platform for regulatory lifecycle management, regulatory processes are streamlined and standardized, optimizing workflow efficiency and improving compliance.
Data management strategies:
- To ensure compliance with regulations, such as ISO IDMP, UDI, SPL, and address data transformation, our data experts assess organizational readiness and identify the future-state business processes and operating model, including the data governance and change management approach. Options for remediation activities include a purpose-built data factory for manual data entry or, for an automated approach, Genpact's digital technologies.
A leading US pharma company preparing for ISO-IDMP regulation readiness transformed their technology infrastructure through process optimization and targeted technology interventions to reduce costs, improve process visibility, and ensure guideline compliance