What We Do
Regulatory Affairs
Generating Regulatory Affairs Impact
Life sciences companies are facing stringent regulatory requirements in developed markets and the challenge of satisfying dramatically variable requirements in emerging markets, resulting in penalties for non-compliance and costly delays. Genpact Pharmalink works with leading life sciences organizations including 9 of the top 10, helping their regulatory affairs functions cut time-to-market, boost efficiency and ensure compliance to deliver superior patient and business value.
Solutions
Genpact Pharmalink's unique Lean DigitalSM approach harnesses the combined power of domain expertise, Lean principles, process-centric digital technologies and design thinking methods to re-imagine regulatory affairs processes end-to-end extending into manufacturing and supply chain. Our solutions include:
CMC Regulatory Affairs
Project-based consulting and outsourcing of CMC strategy, authoring, dossier review and post marketing maintenance from our global delivery centers across the world
Lifecycle Management
End-to-end outsourcing solution for mature products combining global delivery centers of excellence, standardized regulatory processes, operational expertise, and digital performance analytics
Regulatory Operations
Access expert support and scale for peaks in submission planning, dossier compilation, publishing, and large-scale data management projects
Consulting & Technology
Genpact Pharmalink provides a broad range of consulting and technology transformation services to help organizations re-imagine their global regulatory affairs operations and create value for their businesses.
Regulatory Information Management
Genpact Pharmalink provides proven solutions that capture, maintain, and deliver high quality regulatory information to increase productivity, reduce time to market, and ensure compliance for our clients.
Our acquisition of Pharmalink Consulting, a leading provider of regulatory services for nearly all of the 20 largest global life sciences companies for more than 15 years, adds significant depth and specialized expertise to Genpact's regulatory consulting, outsourcing, and technology capabilities.
As Genpact Pharmalink, we deliver custom regulatory affairs projects at any scale, across the globe, providing custom, cost-effective regulatory solutions in over 166 regulated markets, including staff augmentation.
A top 10 pharma company saved more than 25% in costs by implementing our advanced regulatory operating model, by improving quality control and compliance
A top 5 pharma company successfully integrated a merged entity with an accelerated global rollout and change management for new systems and processes to more than 1,500 users in three divisions across chemistry, manufacturing and controls, regulatory affairs, and supply chain departments
