Computational Statistics and Data Analysis Module Development

The contract seeks development of computational statistical modules designed to analyze heterogeneous particle suspensions, employing Euclidean distance metrics and Kolmogorov-Smirnov tests to enable robust root cause analysis and detailed distribution comparisons. The work is focused on creating analytical tools that support quantitative insights into particle behavior and variability, crucial for quality assurance and process understanding in regulated environments. The modules must be scientifically rigorous, computationally efficient, and capable of integrating with existing analytical workflows in pharmaceutical or biologic manufacturing contexts. The solicitation is issued as a subcontract under the NAICS code 541611 for scientific and technical consulting services by the FDA Office of Acquisition and Grant Services, part of the Department of Health and Human Services. Performance is required to occur in Silver Spring, Maryland, with a 20993 ZIP code designation. Proposals must be submitted by May 26, 2026, at 5:00 PM Eastern Time, following a posting date of May 11, 2026. While no set-aside provisions are indicated, the nature of the work implies a technical expertise requirement aligned with advanced data analysis and regulatory compliance standards.