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Storage and labelling of GMP Goods
- Angebotsfrist
- 09.04.26, 11:00 Uhr
- Auftraggeber
- BiconY Therapeutics GmbH
- Ort
- Leipzig, Sachsen
- Veröffentlicht
- 26.03.2026
- Laufzeit
- 01.05.2026 – 31.12.2028
- Verfahren
- Offenes Verfahren
Leistungsbeschreibung
The proper storage of Investigational Medicinal Products (IMPs), GMP-compliant materials, Master Cell Banks (MCBs), and reference standards is a critical requirement to ensure product quality, integrity, and full traceability throughout their lifecycle. All materials must be stored under strictly controlled and continuously monitored conditions in accordance with applicable EU GMP guidelines, ensuring compliance with defined specifications. Therefore, we are looking for a service provider ensuring robust storage systems, including qualified infrastructure, validated monitoring systems, and comprehensive documentation practices fully compliant with regulatory expectations. Please refer to the tender documents for further details.
Eignungsanforderungen
- Please provide the following references. Please use the form provided for this purpose (03_Self-declaration for the eligibility of tenderers) At least three references from reference provider (RP) for the performance of comparable services (The proper storage of Investigational Medicinal Products (IMPs), GMP-compliant materials, Master Cell Banks (MCBs), and reference standards that is robust …
- Self-declaration for the following requirements: - QP authorized to approve products for the EU - GMP-compliant labelling Please use the form provided for this purpose (03_Self-declaration for the eligibility of tenderers)
- GMP Certified: issued by EMA (European Medicines Agency) or internationally recognized equivalent. If more than one facility is involved, a separate certificate needs to be available for each. Please submit a copy the relevant certificate with your offer.
- Self-declaration for the following requirement: Handling of antibodies that are not subject to a specific BSL Please use the form provided for this purpose (03_Self-declaration for the eligibility of tenderers)
Zuschlag / Ergebnis
Ein verifizierbares Zuschlagsergebnis liegt uns noch nicht vor.
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