Information Technology

Gartner Glossary

Global Regulatory Management

Global regulatory management represents key capabilities that a life science company must possess to operate in a global regulatory environment that is increasingly complex and in a state of continuous change. Key capabilities that we will highlight are clinical trial disclosure, product registrations and submission tracking/management. Each capability area addresses a discrete but related need, driven by regulatory authorities around the globe, that must be met to be able to gain product approvals, market authorizations to sell, and management of key processes to maintain compliance in each country that a life science company operates in. These capabilities coexist with and leverage other systems, such as regulatory document management and submission systems.

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