- Country: USA
- Summary: CSS: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease
- UST Ref No: 116860553
- Deadline: 07 Apr 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 75N95025R00039
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- Description:
- Description
STREAMLINED SOLICITATION FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
NON-COMPETITIVE
COMBINED SYNOPSIS / SOLICITATION
Title: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease
(i) This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.
(ii) The solicitation number is 75N95025R00039 and the solicitation is issued as a request for proposal.
This acquisition is for a commercial product or commercial service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Products and Commercial Services; and FAR Part 12—Acquisition of Commercial Products and Commercial Services and is expected to exceed the simplified acquisition threshold.
THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME).
The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), through its Therapeutics for Rare and Neglected Diseases (TRND) program, intends to negotiate and award a contract without providing for full and open competition (including brand-name) to BioAgilytix Labs LLC 2300 Englert Drive, Durham, NC 27713 for development of qualified bioanalytical assay methods and testing of clinical samples collected before and after administration of the AAV gene therapy product.
This acqui... - Documents:
D1-SOW_MMA-BioA-Statement-of-Work-9DEC2024_LC24120.docx
Comb_Synop-Solicit-NONCOMPETITIVE-Bioanalytical-As.docx
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CLICK HERE TO LOGINCSS: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease - 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 CSS: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease. This tender is published on USARFP under UST Ref No: 116860553 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 2025-04-07.
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.
