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Tender Details
- Country: Belgium
- Summary: Ct24-053 - 1
- BET Ref No: 99571036
- Deadline: 06 May 2024
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: Public
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 196061-2024
- Purchaser's Detail :
- Description :
- 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.
Doc Title: CT24-053 - 1
Contract Type: services - Documents :
Purchaser : INSTITUTE FOR RADIOELEMENTS
Address: Avenue de l-Espérance 1
Town: Fleurus
NUTS-Code: BE32B
Postal Code: 6220
Phone: +32 71829556
Email :info@ire.eu
URL :https://www.ire.eu/
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