Tender Details

Country: USA
Summary: Drug Manufacturing and Formulation Program (Dmfp)
UST Ref No: 100836565
Deadline: 15 Jun 2024
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: 75N95024R00077
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
Drug Manufacturing and Formulation Program (DMFP)THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NO. 75N95024R00077, ENTITLED: "NINDS Drug Manufacturing and Formulation Program (DMFP)" WILL BE ISSUED FOR FULL AND OPEN COMPETITION VIA www.SAM.gov ON OR ABOUT May 20, 2024. The National Institutes of Neurological Disorders and Stroke (NINDS) has a continued need for compound formulation and manufacturing services to support the Drug Manufacturing and Formulation Program (DMFP), a component of the Blueprint Neurotherapeutics Network (BPN). The goal of this DMFP requirement is to initiate and complete active pharmaceutical ingredient (API) scale-up and manufacturing to enable candidate molecules to enter clinical stage development. The Contractor in their own facilities and/or through subcontract shall conduct chemical synthesis and development of active pharmaceutical ingredients (API) and manufacture dosage forms of small molecule drug candidates rendering them suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. The Contractor in its own facilities and/or through subcontract shall also conduct process development and preparation of APIs, pre-formulation and formulation studies, analytical method development and validation, stability studies, API/drug product manufacturing, packaging, storage, and distribution. The Contractor shall also prepare data and documentation for all chemistry, manufacturing and controls (CMC) regulatory documents in a format acceptable to the U.S. Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND or New Drug Application (NDA). All work must be conducted in accordance with current Good Manufacturing Practices (cGMP) regulations as required, and as appropriate Good Laboratory Practice (GLP) regulations. The ultimate goal of the BPN and DMFP is to bring...
Documents:

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

Drug Manufacturing and Formulation Program (Dmfp) - USA Tender

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF, a Government sector organization in USA, has announced a new tender for Drug Manufacturing and Formulation Program (Dmfp). This tender is published on USARFP under UST Ref No: 100836565 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 2024-06-15.

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.