Tender Details

Country: USA
Summary: Drug Formulation and Manufacturing Contract II (DFMC)
UST Ref No: 118382488
Deadline: 12 May 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: NIHOD20250424WILLIAMETTI
Purchaser's Detail:
Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details.
Login to see details
Description:
Description
Please take a moment to thoroughly review the attached Statement of Work (SOW), which outlines the full scope and details of the drug formulation and manufacturing contract requirement.
The goal of the contract is to complete all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for investigational drug products. Throughout the period of performance (PoP) of the contract, the contractor must maintain the technical capabilities, minimum resources and organizational compliances with which to successfully conduct any awarded contract activity. The contractor must also maintain a good standing as a “Qualified Vendor” as determined by ORSC. Additionally, unless otherwise requested, any assigned research must be performed in compliance with all current FDA, World Health Organization (WHO), USP, ISO, and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to current good manufacturing practices (cGMP) as may be applicable.
Responses:
Vendors responding to the National Institutes of Health (NIH) issued Sources Sought Note, should review the provided draft Statement of Work (SOW) to identify requirements and deliverables. The vendor-s response should identify and describe how their capabilities and resources will meet the requirements and deliverables they identified in the SOW. While there is no set limit in pages, it is expected that the vendor will be able to briefly respond in an efficient and effective manner.
The initial contract, DFMC-I, was written and awarded in response to sudden changes to the capabilities and resources of the NIH Clinical Center Central Pharmacy. The current proposed contract, DFMC-II, is to build upon the success of DFMC-I. It is expected that for DFMC-II there will be an increase in awarded Task Orders (TOs) due to the current goal of centralizing contracts to support across NIH Enterprise of Institute...
Documents:

If you are registered member, kindly login to view full details of this tender notice:

Drug Formulation and Manufacturing Contract II (DFMC) - USA Tender

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH, a Government sector organization in USA, has announced a new tender for Drug Formulation and Manufacturing Contract II (DFMC). This tender is published on USARFP under UST Ref No: 118382488 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-05-12.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.