Committed to your success, from Concept to Approval.

A Pre-sub, called also Q-Submissions” or “Q-Subs” is a formal written request to FDA made by an applicant

An IDE is a regulatory submission that permits clinical investigation of devices.

A Premarket Notification, also known as “510(k)” is a type of premarket submission made to FDA prior to marketing some medical devices

Means an individual who actually conducts a clinical investigation….

Global Regulatory Partners GK (GRP Japan) is the Japanese affiliate of Global Regulatory Partners US (GRP US)…

UDI System is intended to provide a single, globally harmonized system for positive identification of medical devices….