Life Sciences Regulatory Compliance Solutions

Regulatory Compliance

Drive regulatory compliance excellence through intelligent strategy, comprehensive services and innovative technologies

Cognizant provides a holistic set of services to help life sciences clients keep abreast of worldwide regulatory requirements, design and plan their submission strategies, and streamline their regulatory operations.

Our industry-aligned regulatory compliance solutions and services include:

End-to-end submission strategy optimization for drugs and medical devices, submission publishing, dossier compilation, validation and archival, and post submission documents
Gen AI and machine learning solutions to support document authoring and management
Health authority monitoring to provide global regulatory intelligence updates, analysis reports of impact on submission strategies, standard operating procedures (SOPs), standard work instructions (SWIs) and mitigation plans
System implementations, upgrades, integration services, as well as service requests and incident management

Regulatory operations management

Helps optimize submission strategies and meet global regulations. Offers regulatory operations support, including document authoring, submissions planning, compilation, validation, publishing, tracking, technical review, labeling and database management.

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Regulatory intelligence

Helps you stay abreast of global regulatory changes and delivers comprehensive impact analysis reports on how the changes affect your submission strategy. Leverage AI to develop a strategic mitigation plan, and update documents and internal processes accordingly.

Implementation and managed services

Support integrations across regulatory affairs and functional systems such as regulatory information management systems (RIMS), electronic trial master file (eTMF), product lifecycle management (PLM) and quality systems.