Image Processing, Modeling and Simulation Software

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research, specifically the Division of Product Quality and Research (DPQR), is seeking an advanced cloud-based image processing and analysis software platform. The platform must support high-performance computing capabilities and enable regulatory researchers to assess critical product quality attributes such as content uniformity, microstructural deformation, and release profile. Key technical requirements include a browser-based interface, multi-user support, FDA 21 CFR Part 11 compliance, and advanced machine learning and deep learning image segmentation capabilities. The solicitation will be evaluated using a Lowest Price Technically Acceptable (LPTA) methodology, which will consider both total price and technical features. Vendors must submit electronic quotes by June 13, 2025, at 3:00 PM Washington DC Local Time, with the opportunity posted on June 5, 2025.

The contract is not designated for any specific set-aside and will be a 12-month firm fixed-price contract covering the period from September 30, 2025, to September 29, 2026. The place of performance is located in Maryland, USA, and the contract falls under the NAICS category 541519 for Other Computer Related Services and PSC category DA01 for IT and Telecom Business Application Development Support Services. While specific budget ranges are not explicitly detailed in the solicitation, the contract will leverage the agency's existing high-performance computing (HPC) environment, which can host the cloud-based platform, support high storage requirements, and provide faster image processing capabilities. The procurement is designed to acquire a sophisticated software solution that can predictively simulate critical quality attributes from complex datasets, enhancing the FDA's research and product evaluation processes.