FDA BIMO Inspections and Compliance Support

The U.S. Food and Drug Administration (FDA) Office of Acquisition and Grant Services is conducting market research to identify small businesses on the GSA MAS Schedule capable of providing professional services for Bio-Research Monitoring (BIMO) Inspections and Compliance Support. The primary services sought include developing a unified suite of support tools and systems, providing technical expertise for data and workflow integration, implementing centralized data management solutions, and developing advanced analytics capabilities. Key requirements encompass expanding and maintaining workflow management systems, data integration platforms, site selection tools, and a comprehensive BIMO database with analytics capabilities, along with support in artificial intelligence, end-to-end testing, data architecture, project management, legacy system maintenance, user training, and SharePoint/Power BI support. While this is a Sources Sought Notice rather than a formal solicitation and does not commit the government to award a contract, responses are due by 2:00 PM ET on January 5, 2026, and should be submitted to michelle.dacanay@fda.hhs.gov with a 10-page maximum response length. Interested parties should note that evaluation criteria will focus on the contractor's demonstrated capabilities in consolidating and modernizing FDA's inspection and compliance systems across all centers.

This pre-solicitation notice carries no set-aside designation, and no incumbent contractors or award values are specified at this stage. The Sources Sought Notice does not provide specific budget ranges or contract values, as the primary objective is to conduct market research and identify qualified small business contractors capable of supporting FDA's technological transformation initiatives. The government has not disclosed details regarding the timeline for services or the quantity of work anticipated. Potential respondents should prepare comprehensive responses demonstrating their technical expertise, experience with similar government IT modernization projects, and capabilities in the specialized areas identified, particularly those related to data integration, analytics development, and legacy system support.