CCS Associates, Inc.

CCS Associates, Inc., a woman-owned small business headquartered in McLean, Virginia, delivers regulatory affairs consulting, medical writing, and scientific research support services to federal biomedical and pharmaceutical agencies as a prime contractor (98% of recent awards), competing predominantly under Total Small Business set-asides on single-award and multiple-award IDIQs with the National Institutes of Health. The vendor operates from San Jose, California as its primary place of performance and self-performs all labor with no subcontractor engagement across its federal contract portfolio.

CCS Associates' customer concentration is heavily weighted to NIH institutes, with 91% of awards spanning five distinct NIH sub-agencies. The National Institute of Allergy and Infectious Diseases dominates by potential value — four awards carrying $545.6 million combined ceiling (primarily a single large multiple-award IDIQ) — while the National Cancer Institute leads by award count at 15 awards valued at $101.2 million combined potential. The National Institute on Drug Abuse follows with 14 awards totaling $25 million, the FDA with four awards at $1.3 million, and the National Institute of Neurological Disorders and Stroke and National Center for Advancing Translational Sciences collectively rounding out the active customer set. Recent representative work includes a $15.7 million definitive contract (September 2023) with NCI for regulatory services and technical support to the Division of Cancer Prevention running through 2028 on a cost-plus-fixed-fee structure; an $11.9 million definitive contract with NCI for cancer prevention information management and IND application support for the PREVENT Cancer Preclinical Drug Development Program through 2028; and a $545,690 delivery order from the National Center for Advancing Translational Sciences for regulatory activities supporting PCCA and MMAB gene therapy products under a Total Small Business set-aside through May 2028.

CCS Associates holds two single-award IDIQs anchoring its NIDA work. A $2.4 million IDIQ (awarded September 2023, extending through September 2028) supports regulatory affairs for drug development programs, with recent delivery orders for regulatory preparation and submission support for NIDA's Drug Supply Program clinical trials ($335,910 and $394,539 in consecutive fiscal years). A larger $19.4 million multiple-award IDIQ from NIDA (awarded June 2022, extending through June 2027) encompasses CRO support and regulatory affairs services, generating delivery orders from both NIDA and the National Center for Advancing Translational Sciences. The vendor also holds active contracts under NIAID's Professional, Scientific and Technical Support Services vehicle, including a vendor audit task order completed in April 2024.

SCI-reported invoicing across FY2022–FY2024 totaled $16.6 million (approximately $5.3 to $5.8 million per fiscal year) with a stable workforce of roughly 23 FTEs performing federal services contracts. Government-paid hourly rates on SCI-reportable contracts ranged from a 10th percentile of $110.04/hr to a median of $130.66/hr and a 90th percentile of $175.07/hr, reflecting a mid-tier technical and regulatory consulting profile. Across SCI-reportable prime contracts, the vendor engaged zero subcontractor hours, indicating full self-performance and a direct-delivery model with no layered sub engagement.

Activity over the past five years shows clustering: three awards in 2022, eight in 2023, then one in 2024 and two each in 2025 and 2026. Five awards (combined potential value $28.9 million) carry ultimate completion dates within the next twenty-four months, presenting recompete opportunity. The vendor holds a single sub-award to Axle Informatics, LLC (December 2023) for regulatory support on a decorporation MCM Phase 1 clinical safety study. Total combined potential value across all awards reaches $678.3 million, with $86.2 million obligated (13% drawn).