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.


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:

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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 custom, cost-effective regulatory solutions in over 166 regulated markets, including staff augmentation.

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Insights from Genpact

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