Regulatory Review Support Services

The Regulatory Review Support Services Blanket Purchase Agreement (BPA), established by the Food and Drug Administration (FDA), provides comprehensive information technology and data management support services for regulatory review processes. The contract vehicle encompasses a wide range of technical services, including data standards development, clinical data analysis, IT support, systems maintenance, and software implementation. Task orders under this BPA focus on supporting critical FDA operational needs across various centers and offices, with a particular emphasis on enhancing data quality, regulatory submission processes, and technological infrastructure for medical product review.

International Business Machines Corporation (IBM) has been the predominant prime contractor, winning the majority of task orders with values typically ranging from $200,000 to $20 million and performance periods spanning 1-4 years. Key task order scopes include data standards testing, statistical programming support, clinical services analysis, customer service center operations, and legacy systems maintenance. Booz Allen Hamilton has been a secondary prime contractor, particularly for Advanced Information Retrieval Research System (AIRRS) support services. None of the task orders utilized specific small business set-aside designations, though IBM frequently subcontracted with minority-owned and small disadvantaged businesses like Eclaro International Inc., Callideo, Inc., and Vector Consulting, Inc. The work is predominantly performed in the Maryland/Washington D.C. metropolitan area, supporting the FDA's mission to ensure medical product safety and efficacy through advanced technological solutions.