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.

CPV-Code

73100000

Angebotsfrist

07. Dez 2026, 10:00

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)

Losbezug: LOT-0001 158/003/2026

Annual revenue in the field of activity covered by the contract, based on the last three completed fiscal years, in net EUR at least 4,000,000 EUR per year. (Self-declaration with the tender)

Losbezug: LOT-0001 158/003/2026

Existing liability insurance sufficient to cover interest or potential liabilities under this Agreement including, but not limited to worker’s compensation, if applicable, and comprehensive general liability. (Self-declaration with the tender; certificate from the insurer, or a certificate from an insurer stating that corresponding insurance will be taken out if the contract is awarded to be submitted upon request within 7 calendar days)

Losbezug: LOT-0001 158/003/2026

In case of intended subcontracting, commitment from the subcontractor is secured. (Self-declaration with the tender; a declaration of commitment from each subcontractor to be submitted upon request within 7 calendar days)

Losbezug: LOT-0001 158/003/2026

If a bidder relies on the capacities of other companies to demonstrate its qualifications (economic, financial, technical, and professional capacity) (so-called “qualification lending”), the bidder must prove that the resources required for the contract are actually at its disposal (for technical and professional capacity, the entity from which capacity is borrowed must be a subcontractor; if the bidder relies on the capacities of other companies for economic and financial capacity, these companies must be jointly liable for the performance of the contract). (Self-declaration with the tender; a declaration of liability to be submitted upon request within 7 calendar days).

Losbezug: LOT-0001 158/003/2026

The project manager has at least a C1 level in German or English according to the Common European Framework of Reference for Languages. (Self-declaration with the tender)

Losbezug: LOT-0001 158/003/2026

All studies included in the present tender can be conducted at study sites within the EU, EEA, Switzerland and/or the UK. For studies conducted outside the EU, the bidder can ensure that animal-derived samples can be legally shipped to Germany (Lower Saxony) in compliance with all applicable import and transport requirements, including Regulation (EC) No 1069/2009 and Commission Regulation (EU) No 142/2011, where applicable (Location(s) of the proposed test facility/facilities have to be specified in the project execution concept). (Self-declaration with the tender)

Losbezug: LOT-0001 158/003/2026

Compliant with the OECD Principles of Good Laboratory Practice (GLP) or equivalent OECD-MAD-System principles and national GLP Compliance Monitoring Programs for the applicable studies described in this tender. (Self-declaration with the tender; certificate(s) / statement(s) of GLP compliance covering the applicable areas of expertise to be submitted upon request within 7 calendar days)

Losbezug: LOT-0001 158/003/2026

Authorised and registered for the housing, care and use of laboratory animals and performance of animal experiments in accordance with applicable national legislation. (Self-declaration with the tender; applicable establishment-level authorisation(s), licence(s) or equivalent documentation to be submitted upon request within 7 calendar days)

Losbezug: LOT-0001 158/003/2026

OLAW Assurance available for facilities conducting the applicable animal studies. (Self-declaration with the tender; valid OLAW Assurance documentation to be submitted upon request within 7 calendar days)

Losbezug: LOT-0001 158/003/2026

Qualified and competent personnel available for the planning and conduct of the animal studies described in this tender in accordance with applicable national legislation. (Self-declaration with the tender; Evidence of the required qualifications, competence and/or authorisations to be submitted upon request within 7 calendar days)

Losbezug: LOT-0001 158/003/2026

If applicable at study location, facilities suitable for work with biological agents, including cell cultures, microorganisms and animal-derived samples at the biosafety/protection level (BSL 1) required for the studies described in this tender. (Self-declaration with the tender; Applicable authorisation(s), registration(s), notification(s) or equivalent documentation to be submitted upon request within 7 calendar days)

Losbezug: LOT-0001 158/003/2026

If applicable at study location, compliant with applicable requirements for the handling and use of genetically modified organisms and/or cell systems required for the Ames test and/or hERG assay. (Self-declaration with the tender; Applicable authorisation(s), registration(s), notification(s) or equivalent documentation to be submitted upon request within 7 calendar days)

Losbezug: LOT-0001 158/003/2026

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.

Losbezug: LOT-0001 158/003/2026

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.

Losbezug: LOT-0001 158/003/2026

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.