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HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH has floated a tender for Niaid Clinical Products Center (Cpc). The project location is USA and the tender is closing on 17 Jan 2025. The tender notice number is RFP-NIAID-75N93024R00018, while the TOT Ref Number is 108945535. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country : USA
Summary : Niaid Clinical Products Center (Cpc)
Deadline : 17 Jan 2025
Other Information
Notice Type : Tender
TOT Ref.No.: 108945535
Document Ref. No. : RFP-NIAID-75N93024R00018
Competition : ICB
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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Login to see detailsTender Details
Description
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.
Active Contract Opportunity
Notice ID : RFP-NIAID-75N93024R00018
Related Notice : NIAID-75N93024R00018
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH NIAID
General Information
Contract Opportunity Type: Solicitation (Original)
Original Published Date: Oct 18, 2024 11:07 am EDT
Original Date Offers Due: Jan 17, 2025 03:00 pm EST
Inactive Policy: 15 days after date offers due
Original Inactive Date: Feb 01, 2025
Initiative: None
Classification
Original Set Aside: Total Small Business Set-Aside (FAR 19.5)
Product Service Code: AN12 - HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH
NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Place of Performance: N/A Ax1
Documents
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