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.

Solutions

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.

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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.

Impact

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