Tender Details

Country: USA
Summary: Etonogestrel (ENG) and Ethinyl Estradiol (EE) Testing
UST Ref No: 70533305
Deadline: 29 Aug 2022
Financier: Other Funding Agencies
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: CaseaS_001_RFQ_05_RFQ_02
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Description:
Quotation are invited for Etonogestrel (ENG) and Ethinyl Estradiol (EE) Testing. SCOPE OF WORK The PDI team seeks an analytical laboratory testing company with validated assays and experience in doing ENG and ethinyl estradiol (EE) testing for phase 1 clinical trials. The testing company will analyze a minimum of 1,300 samples. Award is anticipated to be made to one company who will conduct tests for both ENG and EE. Anticipated activities: • Follow Standard Operating Procedures (SOPs) throughout the conduct of the study. SOPs should be available for review by FHI. • Provide essential documentation (e.g., lab director-s CV, lab accreditation info., etc.) to FHI as requested. • Operate in accordance with FDA (21 CFR Part 58) and the Organization for Economic Cooperation and Development (OECD), Good Laboratory Practice regulations, and applicable Good Clinical Practice (GCP) guidelines. • Notify FHI and site (Dominican Republic) upon receipt of samples and report any abnormalities with the shipment and/or samples. • Store samples as specified in the protocol and maintain storage temperature logs. Notify FHI of any temperature excursions. • Accommodate blinding procedures, if required, as specified in the protocol. • Conduct analytical laboratory testing of the samples as specified in the protocol and re-test samples if requested by FHI. • Prepare and submit interim and final result reports to FHI within an agreed-upon timeframe. • Conduct quality assurance reviews per laboratory SOPs. Issue date: 17 Aug, 2022 Closing date: 29 Aug, 2022
Documents:

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Etonogestrel (ENG) and Ethinyl Estradiol (EE) Testing - USA Tender

The FAMILY HEALTH INTERNATIONAL 360, a Government sector organization in USA, has announced a new tender for Etonogestrel (ENG) and Ethinyl Estradiol (EE) Testing. This tender is published on USARFP under UST Ref No: 70533305 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 2022-08-29.

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.