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Non-Clinical Toxicology and safety assessment of a small molecule[E18]

Braunschweig, GermaniaHelmholtz-Zentrum für Infektionsforschung GmbH[E2]

In parole semplici

Cosa cercano
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…
Chi può partecipare
  • Place of performance: Braunschweig, Kreisfreie Stadt (NUTS DE911).
  • Selection criteria (in German): Proof of registration in a professional or commercial registry (e.g., an extract from the commercial registry) (Section 122(2)(1) of the German Act Against Restraints of Competition (GWB) in conjunction with… Mostra di piùSelection criteria (in German): Proof of registration in a professional or commercial registry (e.g., an extract from the commercial registry) (Section 122(2)(1) of the German Act Against Restraints of Competition (GWB) in conjunction with Section 44(1) of the German Public Procurement Regulation (VgV)) or any other certificate or declaration within the meaning of Annex VII, Parts B and C, of Directive 2014/24/EU, if this is a requirement for the lawful practice of the profession under the laws of the respective country of establishment or country of origin. (Self-declaration with the tender; evidence to be submitted upon request within 7 calendar days)
  • The buyer marks the procurement as suitable for small and medium-sized businesses.
  • The procurement is covered by the WTO Government Procurement Agreement.
Scadenza[E8]
Scadenza dell’ente: 7 dic 2026, 10:00 UTC+1. UTC: 7 dic 2026, 09:00 UTC.
Valore
Non indicato dall’ente.
Ente
Helmholtz-Zentrum für Infektionsforschung GmbHGuarda cos’altro acquista questo ente e quando.

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  • Place of performance: Braunschweig, Kreisfreie Stadt (NUTS DE911).[E10]
  • Selection criteria (in German): Proof of registration in a professional or commercial registry (e.g., an extract from the commercial registry) (Section 122(2)(1) of the German Act Against Restraints of Competition (GWB) in conjunction with… Mostra di piùSelection criteria (in German): Proof of registration in a professional or commercial registry (e.g., an extract from the commercial registry) (Section 122(2)(1) of the German Act Against Restraints of Competition (GWB) in conjunction with Section 44(1) of the German Public Procurement Regulation (VgV)) or any other certificate or declaration within the meaning of Annex VII, Parts B and C, of Directive 2014/24/EU, if this is a requirement for the lawful practice of the profession under the laws of the respective country of establishment or country of origin. (Self-declaration with the tender; evidence to be submitted upon request within 7 calendar days)
    [E11]

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Pubblicato[E17]
27 ott 2026
Procedura[E16]
Open procedure
Ultimo controllo
9 ore fa

Sul fabbisogno

Dal bando· Come pubblicato, in Tedesco.

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.[E9]

Ammissibilità e requisiti

I dettagli del bando sono mostrati come li ha pubblicati la fonte. I fatti e i requisiti che estraiamo sono scritti in inglese.

  • CondizionePlace of performance: Braunschweig, Kreisfreie Stadt (NUTS DE911).[E10]
  • Condizione
    Selection criteria (in German): Proof of registration in a professional or commercial registry (e.g., an extract from the commercial registry) (Section 122(2)(1) of the German Act Against Restraints of Competition (GWB) in conjunction with… Mostra di piùSelection criteria (in German): Proof of registration in a professional or commercial registry (e.g., an extract from the commercial registry) (Section 122(2)(1) of the German Act Against Restraints of Competition (GWB) in conjunction with Section 44(1) of the German Public Procurement Regulation (VgV)) or any other certificate or declaration within the meaning of Annex VII, Parts B and C, of Directive 2014/24/EU, if this is a requirement for the lawful practice of the profession under the laws of the respective country of establishment or country of origin. (Self-declaration with the tender; evidence to be submitted upon request within 7 calendar days)
    [E11]
  • CondizioneThe buyer marks the procurement as suitable for small and medium-sized businesses.[E12]
  • CondizioneThe procurement is covered by the WTO Government Procurement Agreement.[E13]
  • DettaglioAward criteria types: price, quality.[E1]

Rischi e incognite

  • SconosciutoThe notice does not state a value.
  • RischioThe official language is German. Documents and bids may need to be in that language.[E15]
  • SconosciutoWe read the published notice, not the full tender documents.

Aggiornamenti

  1. Visto per la prima volta · 28 ott 2026, 09:19 UTC

    The source published a call for competition with a future deadline.

    Documento di origine 743834-2026

Evidenze

18 dati

Ogni dato di questa pagina proviene dal bando pubblicato. Ogni voce indica il documento e il campo da cui è stato letto.

  1. E1

    Award criteria types: price, quality.

    Documento 743834-2026, campo /award-criterion-type-lot, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  2. E2

    The buyer is Helmholtz-Zentrum für Infektionsforschung GmbH.

    Documento 743834-2026, campo /buyer-name/deu, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  3. E3

    The notice is classified under CPV 73110000.

    Documento 743834-2026, campo /classification-cpv/1, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  4. E4

    The notice is classified under CPV 73120000.

    Documento 743834-2026, campo /classification-cpv/3, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  5. E5

    The notice is classified under CPV 73111000.

    Documento 743834-2026, campo /classification-cpv/2, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  6. E6

    The notice is classified under CPV 73100000.

    Documento 743834-2026, campo /classification-cpv/0, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  7. E7

    The buyer is in Germany.

    “DEU”

    Documento 743834-2026, campo /buyer-country/0, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  8. E8

    Tenders must be received by 7 Dec 2026, 10:00 UTC+1.

    “2026-12-07+01:00 10:00:00+01:00”

    Documento 743834-2026, campo /deadline-receipt-tender-date-lot/0, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  9. E9

    The buyer describes the requirement (in German).

    “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…”

    Documento 743834-2026, campo /description-proc/deu, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  10. E10

    Place of performance: Braunschweig, Kreisfreie Stadt (NUTS DE911).

    Documento 743834-2026, campo /place-of-performance, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  11. E11

    Selection criteria (in German): Proof of registration in a professional or commercial registry (e.g., an extract from the commercial registry) (Section 122(2)(1) of the German Act Against Restraints of Competition (GWB) in conjunction with Section 44(1) of the German Public Procurement Regulation (VgV)) or any other certificate or declaration within the meaning of Annex VII, Parts B and C, of Directive 2014/24/EU, if this is a requirement for the lawful practice of the profession under the laws of the respective country of establishment or country of origin. (Self-declaration with the tender; evidence to be submitted upon request within 7 calendar days)

    “Proof of registration in a professional or commercial registry (e.g., an extract from the commercial registry) (Section 122(2)(1) of the German Act Against Restraints of Competition (GWB) in conjunction with Section 44(1) of the German Public Procurement Regulation (VgV)) or…”

    Documento 743834-2026, campo /selection-criterion-description-lot/deu, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  12. E12

    The buyer marks the procurement as suitable for small and medium-sized businesses.

    “true”

    Documento 743834-2026, campo /sme-lot, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  13. E13

    The procurement is covered by the WTO Government Procurement Agreement.

    “true”

    Documento 743834-2026, campo /gpa-lot, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  14. E14

    This is a call for competition. Suppliers can respond. TED notice type: cn-standard.

    Documento 743834-2026, campo /notice-type, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  15. E15

    The procedure title in German is "Non-Clinical Toxicology and safety assessment of a small molecule".

    Documento 743834-2026, campo /title-proc/deu, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  16. E16

    The procedure is: Open procedure.

    “open”

    Documento 743834-2026, campo /procedure-type, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  17. E17

    TED published the notice on 27 Oct 2026.

    “2026-10-27+01:00”

    Documento 743834-2026, campo /publication-date, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

  18. E18

    The notice is titled "Germany – Research and experimental development services – Non-Clinical Toxicology and safety assessment of a small molecule".

    Documento 743834-2026, campo /notice-title/eng, letto 28 ott 2026, 09:19 UTC · fonte (si apre in una nuova scheda)

Source: Tenders Electronic Daily (TED), © European Union. Reuse authorised under Commission Decision 2011/833/EU. Licenza dei dati: EU reuse of TED data (Commission Decision 2011/833/EU) (si apre in una nuova scheda). I recapiti personali presenti nei bandi non vengono conservati né mostrati.