Nichtklinische Toxikologie- und Sicherheitsbewertung eines niedermolekularen Wirkstoffkandidaten
- Status
- Offen
- Angebotsfrist
- 07.12.2026, 10:00 (Europe/Berlin)
- Geschätzter Wert
- Nicht angegeben
- Lose
- 1
- Auftraggeber
- Helmholtz-Zentrum für Infektionsforschung GmbH
- Erfüllungsregion
- Niedersachsen, Deutschland
- Verfahren
- Offenes Verfahren
- Auftragsart
- Dienstleistung · Rahmenvereinbarung
- Veröffentlicht
- 27.10.2026
- CPV-Codes
AnzeigenAusblenden
- Dienstleistungen im Bereich Forschung und experimentelle Entwicklung (73100000)
- Forschungsdienste (73110000)
- Forschungslabordienste (73111000)
- Experimentelle Entwicklung (73120000)
- Bekanntmachung
- subreport.de
- Bekanntmachungsnummer
- 743834-2026
- Verfahrensnummer
- 6415a0b2-dd80-4c2e-9570-02e9bd50bcd2
Fragenkatalog
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Kurzbeschreibung
Das Helmholtz-Zentrum für Infektionsforschung GmbH in Braunschweig beauftragt ein nichtklinisches Prüfprogramm zur Bewertung der Toxikologie und Sicherheit eines niedermolekularen Wirkstoffkandidaten. Untersucht werden sollen insbesondere die Verabreichung als Infusion in eine Vene und mögliche Auswirkungen auf die Nieren; eine ergänzende Prüfung nach Anwendung auf der Haut steht unter einem Go/No-Go-Vorbehalt. Die Ergebnisse sollen eine erste klinische Studie am Menschen und die weitere Entwicklung unterstützen und für Zulassungsunterlagen in der Europäischen Union und den USA geeignet sein; die Angebotsfrist endet am 7. Dezember 2026.
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Leistungsbeschreibung
The overall objective of the present project is to conduct a comprehensive nonclinical toxicology and safety assessment program for a small-molecule drug candidate. The program is intended to characterize the toxicological and safety pharmacology profile of the test item following intravenous infusion and to generate the nonclinical safety data required to support a first-in-human clinical trial and subsequent clinical development. The program shall be conducted in accordance with applicable regulatory requirements and guidelines and shall generate data and documentation suitable for regulatory submissions in the European Union and the United States. Particular attention shall be given to the assessment of renal safety, including the characterization of potential effects of both the test item and the vehicle on renal function and renal toxicity. In addition, the program includes the toxicological assessment of the test item following dermal administration to support the potential clinical evaluation of a semisolid formulation for topical administration. The dermal program is behind a Go/No-Go decision.
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Leistungen nach Losen (1)
LOT-0001 · Non-Clinical toxicology and safety assessment of a small molecule
The overall objective of the present project is to conduct a comprehensive nonclinical toxicology and safety assessment program for a small-molecule drug candidate. The program is intended to characterize the toxicological and safety pharmacology profile of the test item following intravenous infusion and to generate the nonclinical safety data required to support a first-in-human clinical trial and subsequent clinical development. The program shall be conducted in accordance with applicable regulatory requirements and guidelines and shall generate data and documentation suitable for regulatory submissions in the European Union and the United States. Particular attention shall be given to the assessment of renal safety, including the characterization of potential effects of both the test item and the vehicle on renal function and renal toxicity. In addition, the program includes the toxicological assessment of the test item following dermal administration to support the potential clinical evaluation of a semisolid formulation for topical administration. The dermal program is behind a Go/No-Go decision.
Frist: 07.12.2026, 01:00 (Europe/Berlin)
Anforderungen an deinen Betrieb
When submitting the tender, the form "C_02_Self-declaration_EU sanctions"relating to sections 123 and 124 GWB" provided by the awarding authority must be submitted, in which it is declared thatthere are no grounds for exclusion within the meaning of Sections 123, 124 GWB or that sucessful self-cleaningmeasures within the meaning of Section 125 GWB have been carried out. In the case of bidding consortia, the form mustbe submitted by each member of the consortium. Along with the offer, applicants should submit the completedform "C_02_Self-declaration_EU sanctions" provided by the Contracting Authority. In the case of an applicant consortium, eachmember of the consortium should submit the form. The contracting authority reserves the right to request any missing documents at a later date.
Wie wird das Angebot bewertet?
LOT-0001 · Non-Clinical toxicology and safety assessment of a small molecule
- Price The criterion "price" is evaluated on the basis of the following points. The most favourable offer (lowest price) receives a score of 75. The prices of the other offers receive the score depending on the most favourable offer.
- 25 %
- Quality divided into - 45 % Project Execution concept (according to B B_02_project-excecution-concept) - 30 % Capability concept (according to B_03_capability-concept) The criterion "quality" is evaluated based on the following documents: • B_02_project-excecution-concept • B_03_capabilityconcept A maximum of 135 points can be achieved for the project execution concept, representing a maximum of 60% of the quality criterion and 45% of the overall score. A maximum of 90 points can be achieved for the capability concept, representing a maximum of 40% of the quality criterion and 30% of the overall score.
- 75 %
Vergabeunterlagen
2 Dateien laut Portal · Stand 27.10.2026 Bidding_documents_1580032026.zip | Sonstiges | - |
 C_03_Bidder-Questions.docx | Sonstiges | 30 KB |
Anforderungen
When submitting the tender, the form "C_02_Self-declaration_EU sanctions"relating to sections 123 and 124 GWB" provided by the awarding authority must be submitted, in which it is declared thatthere are no grounds for exclusion within the meaning of Sections 123, 124 GWB or that sucessful self-cleaningmeasures within the meaning of Section 125 GWB have been carried out. In the case of bidding consortia, the form mustbe submitted by each member of the consortium. Along with the offer, applicants should submit the completedform "C_02_Self-declaration_EU sanctions" provided by the Contracting Authority. In the case of an applicant consortium, eachmember of the consortium should submit the form. The contracting authority reserves the right to request any missing documents at a later date.
Änderungen und Bieterfragen
0 EinträgeKeine Änderungen zur Bekanntmachung bekannt.
Welche ähnlichen Ausschreibungen sind offen?
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