- Country: USA
- Summary: Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
- UST Ref No: 111010260
- Deadline: 03 Feb 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 75N95025R00005
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- Description:
- Description
The Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation (DPI) at the NationalCenter for Advancing Translational Sciences (NCATS) conducts translational research in the area of humantherapeutics development.
The scope of this contract is for Chemistry, Manufacturing, and Control (CMC) services for Drug Products. Theobjective of these support services is to ensure receipt of formulated Drug Product (DP) of sufficient quality and quantity to support preclinical, IND-enabling and clinical studies.
The Contractor shall provide support for a broad range of preclinical services required for the design, development,manufacture, and release of DP, and release of DP as Clinical Trial Material (CTM), including precursors, preliminarystates, Reference Standards (RS) and all required testing. Ancillary products (e.g., placebos, diluents, adjuvants,master cell banks, testing standards, reference materials) and other materials manufactured or purchased tosupport clinical trials or CMC activities may also be required. All activities preliminary to manufacturing inaccordance with current Good Manufacturing Practice (cGMP) may be required (e.g., development or engineeringlots, formulation studies), even without an associated cGMP manufacturing task. All activities required to maintainmaterial in a usable state, including storage, shipping, testing (in process, release, stability, and quality actions),and preparation of documents to support regulatory submissions may also be required.
Product formats may include small molecules, short oligomeric compounds, biological (large) molecules,quaternary molecular assemblies (homogenous or heterogenous), vectors for gene therapy, nanoparticles, and anyof the above modified genetically, biologically, or chemically. Novel formats identified after this draft might also beneeded. Formats could also include Devices or Combination Products. The breadth of this Statement of Work (SOW) includ... - Documents:
Attachment1-Packaging_and_Delivery_of_Proposals.pdf
Attachment2-Proposal_Intent_Response_Form_FINAL.pdf
Attachment3-Ramp-On-TRND-3-SOW-CMC-DP-8_23.pdf
Attachment4-Sample-TO_Area1_Small-Molecule-4.pdf
Attachment5-Sample-TO_Area2_4.pdf
Attachment6-Sample-TO_Area3_4.pdf
Attachment7-Additional-Technical-Proposal-Instruct.pdf
Attachment8-Project_Objectives_NIH1688-1_mc.pdf
Attachment9-Technical_Proposal_Cost_Summary_mc.pdf
Attachment10-Summary_of_Related_Activities.pdf
Attachment11-FAR_Clause_Deviation_Acknowledgement.pdf
Attachment12-Additional_Business_Proposal_Instruct.pdf
Attachment13-Proposal_Summary_and_Data_Record_NIH.pdf
Attachment14-Breakdown_of_Proposed_Estimated_Costs.xlsx
Attachment15-Offerors_Points_of_Contact.pdf
Attachment16-Disclosure_of_Lobbying_Activities.pdf
Attachment17-Reps-and-Certs-Section-K-Form.pdf
Attachment18-Invoice_Financing_Request_Instructio.pdf
Attachment19-NIH-RC-1_Supplement.pdf
Attachment20-Invoice_FInstructions-for-NIH-Fixed-P.pdf
Attachment21-Quality_Agreement_template.pdf
Attachment22-CMO_Supplier_Audit_Questionnaire.pdf
Attachment23-NIH_Supplier_Qualification_Questionna.pdf
Attachment24_General-Clauses.pdf
Attachment25-QA-Original-RFP.pdf
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CLICK HERE TO LOGINChemistry, Manufacturing and Controls and Related Services for Development of Drug Products - 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 Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products. This tender is published on USARFP under UST Ref No: 111010260 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 2025-02-03.
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.
