FDA Renews Subscription to digiM I2S Microstructure Analysis Platform

The U.S. Food and Drug Administration has renewed its subscription (RFQ-75F40125Q00199) to digiM I2S, a fully integrated image processing platform based on digiM’s proprietary cloud technology. This is the second renewal by the FDA for I2S, with the initial installation of the platform completed in 2023.

digiM I2S , short for Image to Simulation, is an end-to-end software combining data management, artificial intelligence image processing, structural analytics, and image-based simulation. FDA officers in the Division of Product Quality and Research (DPQR) will continue to use the platform to assess the impact of material properties and process parameters on product quality attributes. The renewed subscription extends through 2026, with optional years available through 2028, and includes continued support for a local installation of the cloud platform on the FDA DPQR’s in-house cluster.

This renewal builds on the FDA’s ongoing use of I2S and reflects the agency’s sustained efforts to incorporate advanced imaging, AI-driven analysis, and cloud-enabled tools into regulatory science. By combining real-world imaging data with structural analytics, I2S helps strengthen the connection between manufacturing science and product quality while maintaining high standards of data integrity, auditability, and compliance.

The partnership continues a series of collaborative efforts between digiM and the FDA, including research awards from the Office of Pharmaceutical Quality and grants from the Office of Generic Drugs for assessing Q3 structural equivalence. These initiatives support digiM’s broader mission of transforming drug development through novel analytics and fostering stronger integration between industry and regulatory bodies.