Image Processing, Modeling and Simulation Software

Request for Quotation: 75F40126Q00136 Page 1 of 24 REQUEST FOR QUOTE Image Processing, Modeling and Simulation Software RFQ-75F40126Q00136 Food and Drug Administration (FDA) Request for Quotation (RFQ) Reference #: RFQ-75F40126Q00136 RFQ Title: Image Processing, Modeling and Simulation Software NAICS Code 541519 RFQ Issue Date: 6/16/2026 RFQ Close Date: 6/23/2026 Required Submission Time: 3PM ET F.O.B Point: Destination U.S. Food and Drug Administration White Oak Data Center (WODC) 10903 New Hampshire Avenue Silver Spring, Maryland 20993 Individual Receiving Shipment: Licenses shall be digitally provided. Point of Contact will be provided at award. The Government anticipates awarding a firm fixed price (FFP) purchase order resulting from this solicitation for all items defined in the pricing table. The required delivery date for the items is on or before Sep 30, 2026. This is a combined synopsis/solicitation for commercial products or commercial services in accordance with the format in Federal Acquisition Regulation (FAR) Part 12, as supplemented with additional information included in this Request of Quotation. This announcement constitutes the only solicitation and quotes are being requested. NOTICE OF FAC This procurement is a total small business set aside. The applicable size standard is 150 employees. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-01, effective 13 March 2026. FAR and HHSAR provisions and clauses referenced in this RFQ can be found on the following website: https://www.acquisitions.gov -- 1 of 24 -- Request for Quotation: 75F40126Q00136 Page 2 of 24 Pricing Schedule Table Item No. Description Line Item Type Qty Unit Quoted Price 001 Image Processing Cloud-Based Platform FFP 1 12 Months 002 Delivery, Installation and On-Site Training FFP 1 12 Months 1. SALIENT CHARACTERICTS OF REQUIRED SOFTWARE The Food and Drug Administration (FDA); Division of Product Quality and Research (DPQR) requires an advanced image analysis platform that can provide the reviewers and regulatory researchers to assess the impact of process parameters and material attributes on product quality attributes, such as content uniformity, microstructural deformation, and release profile. A cloud-based powerful image analysis platform can meet these requirements. DPQR has its own high performance computing (HPC) environment. This HPC environment can provide few unique advantages as follows: • Host the cloud-based platform • Support the high storage requirement • Provide faster image processing capability The cloud-based image processing platform should provide a comprehensive workflow, data management, storage management, computing resource management capability. The platform needs to host unique analysis capability that can allow users to quickly analyze and correlate microstructural transformation due to process changes to assess the product’s critical quality attributes. The platform needs to demonstrate a proven track record on solving pharmaceutical and regulatory science challenges involving imaging data. The platform needs to be deployed on FDA HCP clusters with a Linux based system that meets the required specifications. As the system will be installed in FDA DPQR proprietary HPC cluster, there is no security risk. Technical risks on knowledge transfer are mitigated via training and support packages included. Administrative and financial risks are mitigated via annual renewal of the subscription contract. 2. SCOPE The Contractor shall provide the image processing, modeling and simulation software as follows: Item 001: Image Processing Cloud-Based Platform The required technical features of cloud-based image processing software are: • Provide a comprehensive workflow, data management, storage management, computing resource management capability. • Manage and share large volumes of image and quantitative data. • Create and manage complex image processing workflows. • Segment complex imaging data from pharmaceutical samples through the use of traditional, machine learning and deep learning techniques. • Extract quantitative information from complex data that can be used to make real world decisions. • Predictively simulate critical quality attributes of various complex datasets. • Browser based user interface, with multi-user support. • The platform needs to be deployed on FDA HCP clusters with a Linux based system that meets the required system specifications. -- 2 of 24 -- Request for Quotation: 75F40126Q00136 Page 3 of 24 • Quality control, FDA 21 CFR Part 11 Compliance and Audit Trail Support. • Features a digital queue management system preventing users from overloading their computing resources. More or less resources can be allocated as need or lack of need arises. • Cloud-based, fully integrated software platform with proven regulatory science application. • The platform needs to demonstrate a proven track record on solving pharmaceutical and regulatory science challenges involving imaging data The HPC system requirements are: • Google Chrome browser • CPU: 8 core or more • Memory: 128G or more • Instance Storage: 2T or more • GPU • Operating System: Ubuntu 20.04 (or latest version of Redhat if Ubuntu cannot be used) • Software requirements: latest version of Docker and Docker compose should be installed. DPQR HPC environments meet these requirements. Item 002: Delivery, Installation, and On-site training The vendor will cover all costs associated with the following: • System software, shipping, and delivery. • Full system installation in person or screen sharing support on FDA DPQR in house HPC cluster with the help of client’s IT professional. • User training. • On-demand customer support. 3. DELIVERY REQUIREMENTS The above items shall be delivered according to the defined required delivery date The vendor shall deliver all software as detaile…