Graematter, Inc.

Graematter, Inc. is a regulatory intelligence firm that provides advanced software solutions and expert analysis for the medical device and healthcare industries. The company specializes in transforming complex regulatory data into strategic business insights through its proprietary multi-dimensional intelligence platform, SOFIE. Their services are designed to help medical device innovators, investors, and corporate business development teams navigate the complexities of FDA and international regulatory landscapes. The company's core offering, the SOFIE Regulatory Intelligence System, leverages artificial intelligence to provide a comprehensive view across multiple regulatory information sources. This allows users to perform regulatory pathway analysis, competitive technology positioning, and compliance risk assessments. While historically focused on the medtech sector, Graematter has expanded its surveillance capabilities to include pharmaceutical regulatory performance and clinical trial monitoring.