CCS Associates, Inc.

CCS Associates, Inc., a woman-owned small business headquartered in San Jose, California, provides regulatory affairs, scientific consulting, and biomedical research support services as a prime contractor (98% of recent awards) to federal health agencies, primarily the National Institutes of Health, the Food and Drug Administration, and the National Institute of Allergy and Infectious Diseases. The vendor operates predominantly under full-and-open and Total Small Business set-aside designations; woman-owned small business status recurs across the prime footprint.

CCS Associates' customer concentration is heavily skewed toward NIH institutes. The top five funding agencies account for 90% of recent award count, with the National Cancer Institute anchoring the portfolio at 15 awards worth $101.2 million combined potential value, followed by the National Institute on Drug Abuse (13 awards, $5.5 million), the National Institute of Allergy and Infectious Diseases (4 awards, $545.6 million), the National Center for Advancing Translational Sciences (2 awards, $19.9 million), and the Food and Drug Administration (4 awards, $1.3 million). However, the potential-value ranking diverges sharply: NIAID's single large-dollar IDV ($545.5 million) dominates the overall portfolio, accounting for 80% of combined potential value across all awards, while NCI's 15 awards collectively represent 15% of total value. Representative prime work includes a $15.7 million definitive contract from NCI (set aside for Total Small Business, September 2023 through September 2028) for regulatory services and technical support to the Division of Cancer Prevention, encompassing FDA regulatory document preparation, IND application support, and drug dossier development; a $2.4 million single-award IDV from NIDA (September 2023 through September 2028) for regulatory affairs support across drug development programs, with multiple delivery orders issued for clinical trial regulatory preparation and Pre-IND and IND application filing support; and a $545.5 million single-award IDV from NIAID (September 2021 through August 2028) for comprehensive research support spanning clinical trials, manufacturing, nonclinical studies, analytics, regulatory affairs, and biostatistics across infectious, immunologic, and allergic disease research.

CCS Associates holds or sits on five named indefinite delivery vehicles: the NIAID Professional, Scientific and Technical Support Services IDV ($545.5 million, single award, nine-year scope through 2028), the NIDA Regulatory Affairs Support IDV ($2.4 million, single award, through September 2028), the NCATS CRO Support for Regulatory Affairs IDV ($19.4 million, multiple award, through June 2027), and two additional NCI-specific IDVs through parent contracts HHSN261201100016I and 75N95023D00025. Task orders against these vehicles account for a significant portion of the recent award stream — five task orders valued at $7.1 million have flowed through HHSN261201100016I alone.

Activity has been inconsistent year to year: three awards in 2022, eight in 2023, one in 2024, two in 2025, and one in 2026. The recompete cliff is minimal; only five awards (combined potential value $2.8 million) reach ultimate completion inside the next twenty-four months, indicating limited near-term recompete exposure relative to the portfolio's size. This low cliff reflects the dominance of long-duration IDVs with completion dates extending to 2027 and 2028.

On federal services contracts captured in the Service Contract Inventory, CCS Associates self-performs all labor; across SCI-reportable prime contracts, the sub-hours share is zero percent. SCI-reported invoicing ran $5.3 million in FY2022, $5.4 million in FY2023, and $5.8 million in FY2024, with workforce hovering around 23 federal FTEs. Government-paid rates on SCI contracts ranged from a 10th percentile of $110.04 per hour through a median of $130.66 per hour and a 90th percentile of $175.07 per hour, reflecting a mix of senior regulatory and scientific labor priced competitively within the biomedical consulting space. The vendor also holds a cooperative agreement (classified as a federal grant award) from the Center for Drug Evaluation and Research for FDA biomarker qualification research, completed in February 2024.

CCS Associates operates almost exclusively as a prime contractor; one documented sub-award appears in the source — a subcontract to Axle Informatics, LLC on a December 2023 clinical safety study task for regulatory support. The vendor's posture is to build and staff its own delivery teams rather than layer subcontractors, and it does not appear in the sub-award history of other large primes. CCS Associates' capability portfolio centers on regulatory document preparation, IND and Pre-IND application support, clinical trial management and coordination, drug dossier development, medical writing, scientific consulting, and FDA regulatory strategy across therapeutic areas including addiction, cancer prevention, rare diseases, neurological conditions, infectious diseases, and immunologic research. The vendor brings specialized expertise in biomarker qualification, pharmaceutical development pathways, and NIH and FDA regulatory processes, positioning it as a repeatable resource within the NIH enterprise.