Food and Drug Administration (FDA)

SIG

Objective

The FDA needed enhanced project management and strategic support to align modernization efforts, improve schedule tracking, and coordinate across stakeholders. Key challenges included managing complex timelines, dependencies, and responsibilities, while ensuring informed decision-making through accurate reporting, effective communication, and compliance with evolving regulatory and operational requirements.

Solution

SIG supported FDA’s Office of Business Informatics with project management, architecture strategy, and stakeholder coordination. Efforts included master schedule tracking and monthly reporting. SIG also provided paralegal support to the rulemaking process, handling comment review, classification, and data management.

Impact

SIG streamlined schedule tracking, improved cross-team coordination, and delivered consistent, actionable updates for FDA leadership. Strategic guidance enhanced modernization planning, while structured communication fostered stakeholder alignment. Paralegal support enabled efficient comment analysis and reporting, contributing to well-informed policy development and more efficient regulatory decision-making processes.
SIG