Chemistry, Manufacturing and Controls and Related Services Tender

• 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
• Purchaser's Detail:
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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:

 Tender Notice

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