Regulatory preparation, review, and submission for clinical trials associated with nida drug supply program. N01DA-23-8933. April 1, 2025 to march 31, 2026
Ended Awarded Last action
- Contract number
- 75N95025F00001
- Awardee
-
CCS Associates, Inc. UEI VCNRS52G5PG7
- Awarding agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Obligated
- $394,539
Award facts
- Contract value 100% obligated
- $394,539.00 Current and potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- B528 Special Studies/Analysis- Regulatory
- Set-aside
- No set-aside
- Competition
- Full and Open Competition Negotiated Proposal / Quote
- Pricing
- Cost Plus Fixed Fee
- Place of performance
- San Jose, CA 95131, USA
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Exercise an Option | $131,513 | |
| Exercise an Option | $131,513 | |
| Original award | $131,513 |
About this award
The National Institute on Drug Abuse (NIDA) awarded a $394.5K delivery order contract to CCS Associates, Inc., a woman-owned small business based in San Jose, California, for regulatory preparation, review, and submission support associated with clinical trials under the NIDA Drug Supply Program. The contract runs from April 1, 2025 through March 31, 2026 and is structured as a cost-plus-fixed-fee arrangement with no set-aside designation. CCS Associates specializes in regulatory affairs and scientific consulting services for federal biomedical and pharmaceutical research agencies, with particular expertise in preparing critical regulatory submissions such as Investigational New Drug (IND) and Pre-IND applications for various therapeutic areas.
This delivery order is issued under CCS Associates' existing $2.4M single-award Indefinite Delivery Vehicle (IDV) with NIDA for regulatory affairs support, which extends through September 2028. The contractor will provide comprehensive regulatory support services to facilitate the clinical trial process, leveraging its established experience in drug development documentation and regulatory submissions across NIH institutes and the Food and Drug Administration. The company's federal contract portfolio demonstrates significant depth in supporting addiction research and drug development initiatives, positioning it to deliver specialized expertise for this NIDA program.
Quick answers
Who was awarded contract 75N95025F00001?
75N95025F00001 was awarded to CCS Associates, Inc. by National Institute on Drug Abuse (National Institutes of Health) on April 1, 2025.
How much is contract 75N95025F00001 worth?
The government has obligated $394,539 on 75N95025F00001.
Is contract 75N95025F00001 an order under another contract?
Yes. 75N95025F00001 is a delivery order under 75N95023D00025, an indefinite delivery contract.
Was contract 75N95025F00001 competed?
The extent of competition for 75N95025F00001 was full and open competition.
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