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Germany: Tenders/Helmholtz-Zentrum für Infektionsforschung GmbH/Non-Clinical Toxicology and safety assessment of a small molecule

  1. Questions deadline

    Nov 26, 2025 8:00 AMNovember 26, 2025 8:00 AM

  2. Competition notice published

    Oct 23, 11:59 AMOctober 23, 2026 11:59 AM

  3. Tender submission deadline

    Dec 7, 9:00 AMDecember 7, 2026 9:00 AM

  4. Opening date

    Dec 7, 9:15 AMDecember 7, 2026 9:15 AM

  5. Contract start date

    Jan 28, 2027 11:00 PMJanuary 28, 2027 11:00 PM

  6. Tender validity period

    Mar 7, 2027 9:00 AMMarch 7, 2027 9:00 AM

  7. Contract end date

    Jan 27, 2029 11:00 PMJanuary 27, 2029 11:00 PM

Brief

Non-Clinical Toxicology and safety assessment of a small molecule

Deadline
Dec 7,31 days left
Award
Price 25%
Procedure
OpenSingle stage
Agreement
Framework agreementuntil Jan 2029

Brief

Helmholtz-Zentrum für Infektionsforschung GmbH seeks services under a framework agreement to conduct a nonclinical toxicology and safety assessment programme for a small-molecule drug candidate, with delivery in Braunschweig, Germany. The work includes assessing safety after intravenous infusion, with particular focus on renal function and toxicity, and a dermal toxicology programme to support a potential topical semisolid formulation; the dermal work is subject to a Go/No-Go decision. The programme must meet applicable regulatory requirements and produce documentation suitable for submissions in the EU and US, supporting first-in-human trials and further clinical development. The project manager must have C1-level German or English, and applicable studies must comply with OECD GLP or equivalent principles, supported by GLP compliance evidence. Evaluation gives 75% weight to quality (project execution concept 45%, capability concept 30%) and 25% to price.

Forsknings- og utviklingsvirksomhet og tilhørende konsulenttjenester

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Qualification requirements

  • Description

    Leverandøren skal være registrert i et profesjonelt eller kommersielt register (f.eks. et utdrag fra handelsregisteret) eller et annet sertifikat eller erklæring i henhold til vedlegg VII, del B og C, i direktiv 2014/24/EU, dersom dette er et krav for lovlig utøvelse av yrket i etableringslandet eller opprinnelseslandet.

    Documentation Requirement

    Egenerklæring med tilbudet; bevis skal sendes inn på forespørsel innen 7 kalenderdager.

    Source

    No source found in the documents. Check the requirement against the tender documents.

  • Description

    Årlig omsetning innenfor kontraktsområdet, basert på de tre siste avsluttede regnskapsårene, skal være minst 4 000 000 EUR netto per år.

    Documentation Requirement

    Egenerklæring med tilbudet.

    Source

    No source found in the documents. Check the requirement against the tender documents.

  • Description

    Prosjektlederen skal ha minst C1-nivå i tysk eller engelsk i henhold til Det felles europeiske rammeverket for språk.

    Documentation Requirement

    Egenerklæring med tilbudet.

    Source

    No source found in the documents. Check the requirement against the tender documents.

  • Description

    Leverandøren skal overholde OECDs prinsipper for god laboratoriepraksis (GLP) eller tilsvarende OECD-MAD-systemprinsipper og nasjonale GLP-samsvarskontrollprogrammer for de aktuelle studiene beskrevet i denne anbudet.

    Documentation Requirement

    Egenerklæring med tilbudet; sertifikat(er) / erklæring(er) om GLP-samsvar som dekker de aktuelle ekspertiseområdene, skal sendes inn på forespørsel innen 7 kalenderdager.

    Source

    No source found in the documents. Check the requirement against the tender documents.

Award Criteria

  • Description

    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.

    Sub-criteria

    • Project Execution concept60%

      Project Execution concept (according to B B_02_project-excecution-concept). 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.

    • Capability concept40%

      Capability concept (according to B_03_capability-concept). 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.

    Source

    No source found in the documents. Check the weight against the tender documents.

  • Description

    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.

    Source

    No source found in the documents. Check the weight against the tender documents.

Previous winners

  • Who are you up against?

    The suppliers who have won similar contracts at Helmholtz-Zentrum für Infektionsforschung GmbH

From the notice

  • 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.

  • Contact

    einkauf@helmholtz-hzi.de
  • Type
    Competition · Framework agreement
  • Location
    Braunschweig, Kreisfreie Stadt
  • Main code
    Research and experimental development services
    73100000
  • 73110000Research services73111000Research laboratory services73120000Experimental development services

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