INSTITUTE FOR RADIOELEMENTS has floated a tender for Ct24-053 - 1. The project location is Belgium and the tender is closing on 14 May 2024. The tender notice number is 274297-2024, while the TOT Ref Number is 100967165.
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Procurement Summary
Country : Belgium
Summary : Ct24-053 - 1
Deadline : 14 May 2024
Other Information
Notice Type : Tender
TOT Ref.No.: 100967165
Document Ref. No. : 274297-2024
Competition : ICB
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
Purchaser : INSTITUTE FOR RADIOELEMENTS Address: Avenue de l-Espérance 1
Town: Fleurus
NUTS-Code: BE32B
Postal Code: 6220
Phone: +32 71829556 Belgium Email :info@ire.eu URL :https://www.ire.eu/
Tender Details
IRE ELiT is one of the only two global suppliers of germanium-68 (68Ge) / gallium-68 (68Ga) generators approved as a drug in Europe and as an Active Pharmaceutical Ingredient in the United States. More information about IRE Elit germanium-68 (68Ge) / gallium-68 (68Ga) radionuclide generator product characteristics can be found on: https://www.ire.eu/medias/295/UK.pdf. Substances that migrate from a container closure system (CCS) into a drug product formulation can potentially affect its safety, stability and efficacy. Therefore, as part of regulatory compliance, the generator CCS must be assessed for extractables and leachables. Both extractable and leachable reference studies exist for the IRE Elit generator. This procurement notice concerns complementary studies.