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Niaid Clinical Products Center (Cpc) Tender in USA - 108945535

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH has issued a Tender notice for the procurement of a Niaid Clinical Products Center (Cpc) in the USA. This Tender notice was published on 21 Oct 2024 and is scheduled to close on 17 Jan 2025, with an estimated Tender value of Refer Document. Interested bidders can access detailed Tender information, eligibility criteria, and complete bidding documents by referencing TOT Ref No. 108945535, while the tender notice number is RFP-NIAID-75N93024R00018 and Registering on the platform.

Expired Tender

Procurement Summary

Country: USA

Summary: Niaid Clinical Products Center (Cpc)

Deadline: 17 Jan 2025

Posting Date: 21 Oct 2024

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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Tender 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

 Tender Notice

RFP-NIAID-75N93024R00018-Final.pdf


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