What We Do
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.
To better achieve compliance and faster product approvals, we design, transform, and run regulatory affairs processes for our clients, using advanced organizational models, technology and analytics, focused to where they can deliver the most impact. The result is Intelligent OperationsSM.
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
End-to-end outsourcing solution for mature products combining global delivery centers of excellence, standardized regulatory processes, operational expertise, and digital performance analytics
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.
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 cost-effective regulatory support in 166+ regulated markets. Genpact Pharmalink’s regulatory affairs solutions portfolio includes:
- Information management: End-to-end information management transformation for accurate enterprise-wide data and actionable insights, including RIM analysis, XEVMPD remediation and ISO IDMP readiness, with automation technology and an established data factory for accurate data entry
- Consulting and technology: Operating model transformation to drive regulatory compliance and operational effectiveness, enabled by robust technology solutions and advanced analytics
- Staff augmentation: Access over 10,000 global regulatory consultants, to identify and assign regulatory professionals for any role or assignment across the world
Our Smart Enterprise Processes (SEPSM) proprietary framework helps life sciences companies reimagine their regulatory affairs operations by integrating effective Systems of EngagementTM, core IT, and Data-to-Action AnalyticsSM, driving greater compliance, speed to market, and cost efficiency.
A top 10 pharma company saved more than 25% in costs by implementing our advanced regulatory operating model, through better 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.