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Sponsor (RPS)

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This is a Glossary page

This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized

R1 Working Definition

An organization that assumes responsibility for producing and submitting documentation to a Regulatory Authority to seek approval for testing, marketing and the continuation of marketing of new regulated products.

For example, a pharmaceutical company.

ICH Equivalent

None

BRIDG Term

RegulatoryApplicationSponsor

An organization that assumes responsibility for producing and submitting documentation to a regulatory authority to seek approval for testing, marketing and the (continuation of marketing) of new drugs or devices.

For example, a pharmaceutical company.

Additional Regional Definitions and Synonyms