Purchase Order 75N95023P00808
- Not listed
- 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...
- The National Institute on Drug Abuse (NIDA) awarded a delivery order valued at $209,529 to CCS Associates, Inc., a woman-owned small business headquartered in San Jose, California, for regulatory preparation, review, and submission services associated with clinical trials under the NIDA Drug Supply Program. The contract period runs from March 27, 2026 through March 26, 2027, and is structured as a cost-plus-fixed-fee arrangement with no set-aside designation. CCS Associates specializes in...
- This is a five-year, $273,577.07 cost-plus-fixed-fee contract awarded by the National Institute on Drug Abuse (NIDA) to CCS Associates, Inc., a woman-owned small business. The contract provides regulatory affairs support services, including preparing and filing regulatory submissions such as Investigational New Drug (IND) applications and New Drug Applications (NDAs) for NIDA's drug development initiatives across areas like addiction, neurological disorders, and rare diseases. This contract is a...
- This is a Definitive Contract awarded by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), to CCS Associates, Inc., a woman-owned small business. The contract, valued at $106,370.26, is for regulatory affairs consulting support services related to the Brain Program Network (BPN) initiative. The contract was awarded as a Total Small Business set-aside on September 4, 2015 and is scheduled for completion on September 13, 2020. CCS Associates has...
- This is a one-year, $113,077 cost-plus-fixed-fee delivery order awarded by the National Institutes of Health (NIH)'s National Institute on Drug Abuse to CCS Associates, Inc., a woman-owned small business, for regulatory affairs support. The order is part of a larger indefinite delivery vehicle (IDV) that CCS Associates holds from NIH to provide regulatory affairs assistance through 2028. CCS Associates has extensive experience supporting pharmaceutical research, clinical trials, regulatory...
- This is a Delivery Order contract awarded by the National Institute on Drug Abuse (NIDA), part of the Department of Health and Human Services, to CCS Associates, Inc., a woman-owned small business. The contract is for REGULATORY AFFAIRS SUPPORT services with a period of performance from April 1, 2024 to March 31, 2025 and a ceiling value of $307,737.00. This contract does not have a set-aside designation. CCS Associates is an experienced provider of research support services to federal agencies,...
- This is a $48,716.62 federal contract awarded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to CCS Associates, Inc., a woman-owned small business. The contract is for medical writing consultant services to support the National Institute of Neurological Disorders and Stroke (NINDS) Biomedical Preparedness Network (BPN) program. It is a definitive, firm-fixed price contract with a completion date of September 13, 2020. CCS Associates is a contract...
- CCS Associates, Inc. was awarded a $461,849 purchase order by the Department of Health and Human Services' National Institutes of Health National Institute on Drug Abuse to provide medical writing consulting and drug dossier development support services. The contract calls for the contractor to prepare regulatory documents and drug dossiers to support the Blueprint Neurotherapeutics Program, Early Phase Pain Investigation Clinical Network, and other NIH neuroscience research initiatives. Awarded...
- The National Institute on Drug Abuse (NIDA), part of the Department of Health and Human Services, awarded a $16,000 purchase order to Cellx, Inc., a small business, on September 29, 2025, for pharmaceutics formulation, chemistry manufacturing and controls (CMC) consulting services supporting drug discovery and development programs. The contract, which runs through September 28, 2028, provides specialized subject matter expert consultation for small molecules and biologics development, with...
- The National Institute on Drug Abuse (NIDA), part of the Department of Health and Human Services, awarded a $54,000.00 labor-hour purchase order contract to RPK Associates, LLC, a small business, for pharmaceutics formulation and chemistry manufacturing and controls (CMC) consulting services for small molecules and/or biologics. The contract has a base period from September 20, 2025, through September 19, 2026, with optional hours up to 800 total hours per consultant annually. The services...
The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, awarded a $495.8K labor-hour purchase order to CCS Associates, Inc., a woman-owned small business based in San Jose, California, for regulatory affairs consulting support services. The contract, set aside for small businesses and effective through September 2026, will be performed primarily in Rockville, Maryland, with occasional on-site work. Under the original solicitation, CCS Associates will provide senior-level regulatory expertise and guidance to support NIDA's drug development programs, advising on regulatory strategies and reviewing submissions for treatments targeting nervous system conditions and addiction-related disorders. CCS Associates specializes in regulatory affairs, scientific consulting, and research support services for federal biomedical and pharmaceutical research entities, with extensive experience preparing regulatory documents such as Investigational New Drug and Pre-Investigational New Drug applications. The company maintains a robust relationship with NIDA and other NIH institutes, including a $2.4M indefinite delivery vehicle contract with NIDA for regulatory affairs support through September 2028. This award represents one of multiple federal contract vehicles through which CCS Associates delivers critical regulatory and scientific support across the NIH enterprise.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
Regulatory Affairs Consultant Support Services | 75N95023R00065 | Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse | Award Notice 3/3 | 9/28/23, 11:48 AM | |
Regulatory Affairs Consultant Support Services | 75N95023R00065 | Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse | Award Notice 2/3 | 9/28/23, 11:40 AM | |
Regulatory Affairs Consultant Support Services | 75N95023R00065 | Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse | Solicitation 1/3 | 7/20/23, 12:48 PM |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00006 | Exercise an Option | $31.8k | 9/5/25 | |
| P00005 | Exercise an Option | $57.9k | 1/22/25 | |
| P00004 | Exercise an Option | $38.6k | 10/31/24 | |
| P00003 | Exercise an Option | $67.5k | 7/22/24 | |
| P00002 | Exercise an Option | $30.9k | 3/12/24 |