Image Processing, Modeling and Simulation Software

Summary (Newest Update)

Background The Food and Drug Administration (FDA), specifically the Division of Product Quality and Research (DPQR), is seeking an advanced image analysis platform to assist reviewers and regulatory researchers in evaluating how process parameters and material attributes affect product quality attributes such as content uniformity, microstructural deformation, and release profiles. The goal is to implement a cloud-based image analysis platform that can leverage the FDA's high-performance computing (HPC) environment. Work Details The contract involves providing an Image Processing Cloud-Based Platform with the following specifications: - A comprehensive workflow, data management, storage management, and computing resource management capability. - Ability to manage and share large volumes of image and quantitative data. - Creation and management of complex image processing workflows. - Segmentation of complex imaging data from pharmaceutical samples using traditional, machine learning, and deep learning techniques. - Extraction of quantitative information from complex data for real-world decision-making. - Predictive simulation of critical quality attributes from various datasets. - A browser-based user interface supporting multiple users. - Deployment on FDA HPC clusters with a Linux-based system that meets specified requirements. Pricing Schedule: 1. Image Processing Cloud-Based Platform: 1 unit for 12 months (FFP) 2. Delivery, Installation, and On-Site Training: 1 unit for 12 months (FFP) Period of Performance On or before September 30, 2026. Place of Performance U.S. Food and Drug Administration, White Oak Data Center, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993. Bidder Requirements This procurement is a total small business set aside with an applicable size standard of 150 employees. Bidders must provide licenses digitally. Incumbent Analysis (see Incumbents section for more detail) This opportunity appears to have a confirmed incumbent, with Digim Solution holding two prior FDA contracts for “Image Processing, Modeling and Simulation Software” (75F40123P00369, $329,470, 09/06/23–09/29/28 and 75F40125P00167, $91,390, 08/05/25–09/29/26). The prior work title and scope align closely with the current requirement for an image analysis platform that supports modeling/simulation and quantitative extraction from complex imaging data, including deployment within FDA HPC environments. The overlap in software purpose suggests the current effort may be a continuation or expansion of the incumbent’s existing image processing/modeling capabilities.