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Tender Details
- Country: USA
- Summary: Drug Manufacturing and Formulation Program (Dmfp)
- UST Ref No: 101299562
- Deadline: 23 May 2024
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: Public
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 75N95024R00077
- Purchaser's Detail :
- 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 24, 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 :
Purchaser : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Contracting Office Address : Bethesda , MD 20892
Primary Point of Contact : PLUGGE, RIEKA N
rieka.plugge@nih.gov
Phone Number +1 301 827 7515
Email :rieka.plugge@nih.gov
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