CMC Regulatory Affairs

Understand cloud costs, transform workloads, and govern investments effectively

Improve operations and compliance for chemistry, manufacturing, and controls (CMC) organizations

Increasing regulatory complexity and mergers overwhelm CMC organizations. Genpact's CMC Regulatory Affairs solution addresses this by optimizing operational models. It offers technical staffing, consultancy, and managed services across the application life cycle, from new drug applications to maintenance. Using technology and analytics, it improves efficiency, compliance, and performance across the product life cycle.

Enhance current regulatory operating models with process and technology tools that achieve incremental productivity gains.

Improve efficiency by up to

20-30%

with a focus on routine life cycle management

CMC Regulatory Affairs: Solution portfolio

Genpact Regulatory Affairs helps life sciences firms scale regulatory operations services and move to operating models that meet their needs.

 

Our industry experts enable clients to evolve their operating models using the right mix of process and advanced technology skills to achieve new levels of operational efficiency and performance.

Why Genpact Regulatory Affairs?

  • We deliver integrated regulatory affairs solutions to top life sciences firms

  • Work with our team of professionals in global centers of excellence

  • Flexible delivery models for maximum value

  • Local regulatory insight, strategy, and intelligence, and expertise in local languages

  • Our Smart Enterprise ProcessesSM methodology standardizes regulatory workflows against best practices

  • Advanced technologies offer real-time analytics and insights

Case study: End-to-end CMC services driving regulatory success

A major pharma firm wanted to cut costs and balance new product development and product life cycle management in a dynamic CMC regulatory environment.

 

Genpact Regulatory Affairs offered customized services, including CMC life cycle management support that helped with ancillary documentation, tender support, and the certificate of pharmaceutical products.

 

Our CMC life cycle work freed staff to focus on higher priority tasks, accelerated submissions, and increased the percentage of winning tenders.

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