GlobalSubmit - Synchrogenix Employee Directory

Computer SoftwarePennsylvania, United States11-50 Employees

GlobalSubmit - Synchrogenix operates as a software development and services firm dedicated to electronic regulatory submissions for life sciences companies and the regulatory agencies that oversee them worldwide. It combines software platforms with publishing services, eCTD outsourcing, regulatory consulting, and technical support to help clients manage submission workflows and maintain regulatory compliance. Headquartered in Philadelphia, Pennsylvania, the company also maintains satellite offices in Research Triangle Park, North Carolina, and Boston, Massachusetts. Since 2005, GlobalSubmit has held an exclusive contract with the U.S. Food and Drug Administration, and its REVIEW and VALIDATE software are used by the FDA to assess the technical validity of electronic submissions it receives. Its client base includes life science firms and regulatory agencies worldwide, which rely on its services to prepare and validate electronic submissions. In the software development landscape for regulatory affairs, the company occupies a specialized niche that integrates software platforms with professional services to support end-to-end submission processes.

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