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Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), including those that are imported for export only, are required to register annually with the FDA.
Most establishments that are required to register are also required to list their devices and the activities performed on those devices at that establishment (Title 21 CFR Part 807)
To know more please check our whitepaper.
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.