SAM #75N98026Q00734

Refrigerated Storage and FDA-Compliant Labeling of Investigational Drug Sachets

The National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, is seeking long-term refrigerated storage and FDA-compliant labeling services for an investigational drug. - Government Buyer: - Agency: National Institutes of Health - Sub-agency: National Human Genome Research Institute (NHGRI) - OEMs and Vendors: - Eminent Services Corp (selected for award) - Products/Services Requested: - Refrigerated storage of investigational drug (powder-in-sachets) - 16 boxes, each with 600 sachets (total: 9,600 sachets) - Strict temperature control required - Must meet FDA regulatory requirements - FDA-required in-house drug labeling - Labeling must match previous Phase 2 clinical trial design with updated information - Unique/Notable Requirements: - Vendor must be familiar with the specific investigational drug - In-house labeling capability to avoid re-shipment - Storage and handling must comply with FDA regulations - Drug intended for future clinical trials for GNE-related thrombocytopenia and nephrotic disease

Description

Attachment: Notice of Intent

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