FDA BIMO Inspections and Compliance Support

The U.S. Food and Drug Administration (FDA) is seeking sources to provide professional services for FDA Inspections and Compliance Support. The purpose of this Sources Sought notice is to identify small businesses with the capabilities to provide these services. The FDA is looking for contractors who can support the development, enhancement, implementation, and maintenance of a broad range of tools and functions to support FDA's Inspection and Compliance programs. Some key areas of focus include: • Workflow Management: evaluating and enhancing existing BIMO inspections and compliance workflow systems • Data Integrations: expanding and enhancing data management solutions to serve as the primary data hub for inspections and compliance activities • Inspection Support Tools: maintaining and enhancing inspection and compliance tools, including Site Selection Tools • BIMO Database and Analytics: developing and maintaining a comprehensive, agency-wide central repository for all FDA BIMO inspection and compliance data • Other Program Support Areas: providing support for Artificial Intelligence (AI) expertise, End-to-End (E2E) testing, Data Architecture expertise, Project Management support, Legacy System support, Training, and SharePoint and Power BI support.