Smart Consulting Group LLC

Smart Consulting Group LLC, an SBA-certified women-owned small business based in West Chester, Pennsylvania, operates as a prime contractor delivering regulatory compliance, program management, and management consulting services to federal civilian agencies. The vendor operates exclusively in prime roles—100% of recent awards are prime contracts—with no subcontract footprint, and competes in full-and-open (non-set-aside) procurements on the GSA Multiple Award Schedule.

Smart Consulting's customer base is concentrated with a single agency. The Food and Drug Administration accounts for 4 of 5 awards totaling $1.4 million in combined potential value (74% of total activity), with a secondary $500 thousand award under GSA Federal Acquisition Service. The vendor's most recent and largest award is a $607,211.51 firm-fixed-price delivery order from FDA, issued September 30, 2021, for the development of strategies in handling high-profile consent decrees, with performance through July 1, 2025. Earlier awards include FDA regulatory compliance and management consulting work spanning 2009 through 2016. Across the top-customer rankings, FDA dominates both award count and dollars—the two rankings are identical, reflecting no diversification across multiple agencies or dollar tiers.

Smart Consulting places all recurring work on the GSA Multiple Award Schedule, with 3 task orders (combined potential value $1.3 million) under that vehicle. The broader award portfolio spans 5 total awards with $1.9 million in combined potential value and $1.2 million obligated to date; activity has been sparse and episodic—one award each in 2009, 2012, 2015, 2016, and 2021—with no awards issued in the interval 2017–2020 or since 2021. The vendor's NAICS classification splits between Administrative Management and General Management Consulting Services (4 awards) and Other Scientific and Technical Consulting Services (1 award), with PSC coding across program management support and legal support categories.

Service Contract Inventory data covering FY2022–FY2024 shows minimal federal service-contract activity: only $32 thousand in SCI-reportable invoiced revenue in FY2024 (0.1 FTEs), with zero invoicing reported for FY2022 and FY2023. This reflects either light utilization of existing vehicles or incomplete reporting in the SCI dataset and should not be interpreted as total federal revenue. On GSA Schedule labor pricing, Smart Consulting offers five labor categories spanning $66.75 per hour (entry-level Project Management Data Coordinator, associate's degree, one year experience) through $244.73 per hour (Executive Consultant, master's degree, ten years experience), with all positions unclassified. The pricing spectrum reflects a capability mix from coordinator-level administrative support through senior management consulting, with no specialized cybersecurity, engineering, or cleared-labor offerings. Sub-engagement is zero—the vendor self-delivers across all reported prime contracts with no named subcontractors.

Smart Consulting Group is a progressive consulting company that is providing technical, quality compliance and regulatory assistance to the healthcare industry with specific focus on:

?Pharmaceuticals

?Biotechnology

?Biologics

?Medical Devices

Services include:

* Subject Matter Expert Support for medical product development and licensure, including CBRN products

* Development of a Quality Strategy

* Building comprehensive Quality Systems together with implementation of integrated Quality System Elements

* Experience with global concerns and implementation

* Change Management, Investigations, CAPA, OOS, document systems, audits, risk management and GMP information system support.

Compliance Remediation Programs for FDA483's, Warning Letter and Consent Decrees/Application Integrity Policy.

Custom courses are available for a variety of topics as well as individual mentoring type coaching, which provides experienced one-on-one training and guidance