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

Do aviso· Como publicado, em Alemão.

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]

Os detalhes do aviso aparecem como a fonte publicou. Os fatos e requisitos que extraímos estão em inglês.

• CondiçãoPlace of performance: Braunschweig, Kreisfreie Stadt (NUTS DE911).[E10]
• Condição
  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… Mostrar maisMostrar menos

  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)
  [E11]
• CondiçãoThe buyer marks the procurement as suitable for small and medium-sized businesses.[E12]
• CondiçãoThe procurement is covered by the WTO Government Procurement Agreement.[E13]
• DetalheAward criteria types: price, quality.[E1]

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

1. Vista pela primeira vez · 28 de out. de 2026, 09:19 UTC

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

   Documento de origem 743834-2026

Cada dado desta página vem do aviso publicado. Cada item mostra o documento e o campo de onde foi lido.

1. E1

   Award criteria types: price, quality.

   Documento 743834-2026, campo /award-criterion-type-lot, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

2. E2

   The buyer is Helmholtz-Zentrum für Infektionsforschung GmbH.

   Documento 743834-2026, campo /buyer-name/deu, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

3. E3

   The notice is classified under CPV 73110000.

   Documento 743834-2026, campo /classification-cpv/1, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

4. E4

   The notice is classified under CPV 73120000.

   Documento 743834-2026, campo /classification-cpv/3, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

5. E5

   The notice is classified under CPV 73111000.

   Documento 743834-2026, campo /classification-cpv/2, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

6. E6

   The notice is classified under CPV 73100000.

   Documento 743834-2026, campo /classification-cpv/0, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

7. E7

   The buyer is in Germany.

   “DEU”

   Documento 743834-2026, campo /buyer-country/0, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

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, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

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, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

10. E10

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

    Documento 743834-2026, campo /place-of-performance, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

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, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

12. E12

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

    “true”

    Documento 743834-2026, campo /sme-lot, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

13. E13

    The procurement is covered by the WTO Government Procurement Agreement.

    “true”

    Documento 743834-2026, campo /gpa-lot, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

14. E14

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

    Documento 743834-2026, campo /notice-type, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

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, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

16. E16

    The procedure is: Open procedure.

    “open”

    Documento 743834-2026, campo /procedure-type, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

17. E17

    TED published the notice on 27 Oct 2026.

    “2026-10-27+01:00”

    Documento 743834-2026, campo /publication-date, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

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, lido 28 de out. de 2026, 09:19 UTC · fonte ↗ (abre em nova aba)

Source: Tenders Electronic Daily (TED), © European Union. Reuse authorised under Commission Decision 2011/833/EU. Licença dos dados: EU reuse of TED data (Commission Decision 2011/833/EU) ↗ (abre em nova aba). Dados de contato pessoais dos avisos não são guardados nem exibidos.