Regulatory affairs

Reimagine your regulatory services and operations to speed drugs and devices to patients who are in need

regulatory affairs
regulatory affairs

Overview

We partner with life sciences companies to help keep patients safe. We combine our industry expertise with advanced technology, data management, and advanced analytics to transform regulatory operations and drive growth while maintaining compliance.

The 6Cs driving competitive advantage in regulatory affairs

In an ever-changing and heavily regulated environment, we see six key drivers of change in regulatory affairs (RA). Leading RA teams are ready to adapt to drive competitive advantage and meet the future needs of their businesses while keeping patient safety at the heart of everything they do.

Through investment in technology, analytics, and capabilities, digital transformation in regulatory affairs delivers better outcomes for both the business and the people it serves.

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Featured solutions

With over 20-years' experience in RA, our team of 5,000 consultants transform and run your regulatory operations for robust compliance and successful marketing authorizations and supply transfers.

CMC compliance

Our advisory services transform regulatory policies and processes related to chemistry, manufacturing, and controls (CMC) to enable sustainable compliance.

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Data enrichment and migration

Our data-migration methodology collects and cleanses data with minimal disruption.

AI document-to-data tools

Extract data from documents at speed and scale with our AI and machine-learning technologies that use optical character recognition and natural-language processing.

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Genpact Regulatory as a Service (GRaaS)

Benefit from our breadth of RA expertise, process excellence, and digital solutions with our GRaaS pre-configured technology platform.

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IDMP compliance

Get ready for IDMP with our expert assessment and advisory services. Gain data-level status reports and analytics in terms of availability, accuracy, and integrity for your current data.

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Marketing authorization supply transfer (MAST)

Our MAST tool integrates MDM and regulatory information management with real-time planning, forecasting, and submission tracking into a single dashboard for successful supply transfers.

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Master data management

Consolidate and standardize your data across regulatory, quality, and supply functions in line with IDMP standards and the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).

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Mergers, acquisitions, and divestitures

Our advisory services drive planning, implementation, and maintenance activities for MA&D projects.

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Product lifecycle management

Our RA center of excellence offers post-approval maintenance services including regulatory authoring and CMC, submission management, publishing, regulatory operations, and product strategy management.

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Robotic process automation

Transform your RA operations and boost productivity with automation and AI.

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Submissions management

We manage your submissions documents, publishing, and archiving in line with ICH guidelines.

Regulatory information management

We partner with Veeva to bring you the latest cloud-based regulatory information management system to help you standardize and manage your submissions data in line with IDMP.

5 K

regulatory affairs consultants

+ 120

countries served

+ 20

years in business

Unburden your regulatory teams with Genpact Regulatory as a Service

Reduce the labor-intensive tasks of RA with our comprehensive technology platform.

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