Life sciences Regulatory Affairs

Reimagine the life sciences value chain with transformed regulatory strategy and operations for superior compliance and efficiency
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Our team of 5,000+ consultants across global delivery centers drives transformation and improves regulatory compliance with domain expertise and digital technology.

Digital solutions unlock growth and value for some of the world's largest life sciences firms.

Our regulatory affairs experts design and execute transformation roadmaps so that your operating model delivers on your business goals. Our digital technologies and advanced analytics enable you to grow and stay compliant.

5K

regulatory affairs consultants

120+

countries served

20+

years in business

We have products and solutions that fit your needs

1. Our advisory services engage with clients with an emphasis on strategic thinking. We provide solutions backed by deep industry and process knowledge and digital advisory services.

2. Our managed services offer end-to-end business process management across the product lifecycle, including chemistry, manufacturing, and controls (CMC), regulatory operations, labeling, and lifecycle maintenance activities.

3. Our digital suite of products and services transforms regulatory, from support to automation, with advanced technologies, including Genpact Cora RegAssure, data management capabilities, process automation, and system implementation.

Select the products and solutions below for more details:

Advisory Services

2 Products & Solutions

Mergers, acquisitions, and divestitures (MA&D)

MA&D transactions are complex and high stakes. Our clients typically face multiple challenges, such as significant delays in completing integration per original plans, disruption in supply and its impact on brand image, the lack of active management of third-party distributor contracts and licenses, and compliance issues.

With expertise built up through more than 20 years of experience, Genpact Regulatory Affairs supports clients in planning, implementation, and maintenance activities for MA&D projects.

CMC compliance

Genpact provides superior CMC compliance and greater transparency with a future-oriented solution defined by clear processes and strong governance. Our team of CMC and quality experts ensures proactive compliance in line with changing regulatory requirements to support the uninterrupted supply of medicines to patients.

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Managed Services

3 Products & Solutions

Product lifecycle management solution

Genpact has been driving innovation in post-approval maintenance activities for top pharmaceutical organizations through its center of excellence in regulatory authoring and CMC, submission management, publishing, and regulatory operations along with three regional hubs for strategy management across product portfolios.

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Submissions management/publishing/CMC center of excellence

Genpact Regulatory Affairs has expertise in publishing across all modules defined under ICH guidelines, such as submission management, publishing, archiving, and ancillary documents.

Genpact's Regulatory as a Service (GRaaS)

Our GRaaS solution offers our services (in domain expertise, process excellence, and digital solutions) bundled with a preconfigured technology platform to our clients. A spectrum of services is also available – from ancillary document management (as a service) to publishing (as a service) and full portfolio lifecycle management (as a service).

Digital

5 Products & Solutions

Data/IDMP management

Our team comprises dedicated regulatory information management (RIM), master data management (MDM), identification of medicinal products (IDMP), and eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) experts who have been advising clients on the Medicinal Product Dictionary since 2003.

We have also supported various clients with XEVMPD data remediation and ISO IDMP-readiness projects. Our IDMP expertise includes IDMP assessment with data-level status reports and analytics in terms of availability, accuracy, and integrity.

Data enrichment and migration

Our proven data-migration methodology ensures effective migration – by collecting and defining data, building proof of concept, and leveraging data deduplication and delta extraction techniques with minimal disruption.

Document-to-data transformation using AI

Extract metadata from CMC documents for a speedier, consistent response to queries from health authorities. This capability can be developed in many other situations such as system migrations and MDM.

RPA solution

Robotics process automation (RPA) is an alternate process-transformation option driving value with high execution speed and ROI. Our preconfigured systems for rapid deployment coupled with the effective use of digital tools, such as robotics and artificial intelligence (AI), boost productivity.

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Cora RegAssure

Applying intelligent automation (including RPA and AI) to regulatory processes can improve efficiency by 40% and enhance compliance by reducing errors in data collection and collation, comparative analysis, adjudication, and remediation. Our preconfigured systems for rapid deployment and digital tools enhance productivity and accuracy and make processes seamless.

Find answers to your business needs.