Niaid clinical products center (CPC)
Closed Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- RFP-NIAID-75N93024R00018
- Agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- N/A Unknown
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is seeking to award a contract for centralized services to support NIAID's pharmacy and pharmaceutical oversight responsibilities for national and international clinical trials. The key requirements include study product management, regulatory document maintenance, co-submissions of Drug Master Files and stability studies, and a clinical samples repository with testing services. The contract will have a base period of one year with up to 41 option periods. Proposals are due by January 17, 2025 at 3:00 PM Eastern Time.
This solicitation is set-aside for small businesses. The estimated cost for the base period and options is to be determined. The place of performance is not specified. There are no details provided about any potential incumbent contractors.
Notice text
The purpose of this contract is to provide support to NIAID OPRM for the pharmacy and pharmaceutical oversight responsibilities of national and international NIAID/DAIT supported clinical trials as well as other NIH funded clinical trials on an as-needed basis, to ensure study product integrity, participant safety, pharmacy and pharmaceutical regulatory compliance. This contract provides NIAID with centralized services for: 1) Study Product (i.e., IP management, procurement, receipt, storage, labeling, packaging/repackaging, blinding (i.e., over-encapsulation); placebo manufacturing, sterile product manufacturing and preparation, blister packaging, distribution to site, inventory management, accountability, disposal, and expiration dates and recall monitoring); 2) IP Regulatory Document Maintenance in the DRMC (Regulatory documents relating to shipment, receipt, disposition, return, destruction, manufacturing (placebo, food product immunotherapy, etc.), over-encapsulation (for blinding purposes), stability/sterility protocols and testing, and labeling and packaging; 3) Co-submissions of Drug Master Files (DMFs) and co-conducting product stability studies; and 4) Clinical samples repository, product sterility/stability and release testing, clinical laboratory testing such as Immunoassays, Molecular Diagnostics, DNA Sequencing, Flow Cytometry, etc.
Files
| File | Type | Posted |
|---|---|---|
| RFP-NIAID-75N93024R00018 Final.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Niaid clinical products center (CPC) | Award Notice | |
| This notice | Solicitation | |
| Niaid clinical products center (CPC) | Pre-Solicitation | |
| Niaid clinical products center (CPC) | Pre-Solicitation |
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