CMC Regulatory Affairs

Reimagine your CMC regulatory affairs operating model to enhance compliance

Group of happy healthcare workers and business people applauding after successful seminar in convention center.

We're a leader in life sciences regulatory and medical affairs. Read the report

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

Consolidate operations across divisions by transforming your operating model with CMC services in each business unit.

Make the transition to realize up to

the efficiency benefits with specialized, standardized operations

Externalize maintenance for mature products with strategic outsourcing to sustain long-term efficiency gains.

Sustain efficiency gains up to

10X

with strategic partnerships

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 Processes^SM 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.