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Non-Clinical Toxicology and safety assessment of a small molecule
DEGermany · Braunschweig
Your path to submission
- Deadline: 7 December at 10:00 — 36 days left.
- The submission point is stated in the notice (link on this page).
- Offer and evidence in: German.
- Collect your evidence — use the eligibility analysis on this page: it lists the requirements and, for known certificates, how to get them.
Compiled automatically from notice and documents — no guarantee; the procedure's wording is binding.
What the buyer is looking for
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…
Show full description
… 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.
Machine translation (EU eTranslation) — official wording via the PDF link.
Contract
TypeServices
Estimated valuevalue not published
Published27 Oct 2026
ProcedureOpen procedure
Contract period29 Jan 2027 → 28 Jan 2029
Framework agreementReserved for SMEs
Type of service
73 · R&D services
CPV 73100000 · 73110000 · 73111000 · 73120000
Clement What the numbers say about this buyer
- In this sector the buyer awards roughly every 20 months (10 awards, most recently May 2025) — the next award is due around January 2027 by that rhythm. The last award went to Ardena Holding N.V.n = 10
- The award came in at a median 132% of the estimated value (13 awards with both estimate and value) — pricing at the estimate is usually too low here. Sector: 96%.n = 13
- 38% of this buyer's awards went to companies that had already won here before (198 awards since 2018, spread over 123 companies). 62% went to new names.n = 198 awards since 2018
- 17% of the bids received came from other countries (8 procedures with a bid mix) — all bidders, not just the winners. Sector: 32%.n = 8
- The median procedure drew 2 bids (171 procedures with a bid count); 45% ended with a single bidder. Sector: median 1 bid.n = 171
From this buyer's documented awards; comparison values from the same sector and country. Not a forecast, not legal advice. As of 01/11/2026.
Clement
In this buyer's last 10 comparable contracts (same sector), usually only 2 offers came in — a solid bid has real chances.
References and certificates from your home country count fully across the EU — that is what European procurement law is for.
What you must prove — eligibility criteria
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Trade register enrolment
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 Regul… read in fullcollapse
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)
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Other economic requirement
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)
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Other economic requirement
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… read in fullcollapse
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)
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Other economic requirement
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)
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Other economic requirement
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 ac… read in fullcollapse
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).
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Staff qualifications
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)
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Other economic requirement
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) i… read in fullcollapse
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)
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Quality management
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)… read in fullcollapse
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)
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Quality management
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)
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Quality management
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)
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Staff qualifications
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)
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Quality management
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-declarat… read in fullcollapse
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)
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Quality management
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),… read in fullcollapse
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)
Requirement texts are quoted in the notice's original language — only the official wording is binding.
Tender documents — direct download
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Annex 1
Specifications and annexes at the buyer — usually viewable without registration
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Administrative conditions
The full notice, official wording
Who has won at this buyer so far
Across all contract types of this buyer — not just this sector. A city buys software and fire engines through the same purchasing office.
| Company | Awards | Period |
|---|---|---|
| Becton Dickinson GmbH | 12 | 2007–2023 |
| Thermo Fisher Scientific GmbH | 8 | 2008–2021 |
| 10x Genomics, Inc. · Pleasanton | 8 | 2025 |
| Bruker Daltonik GmbH · Bremen | 7 | 2008–2019 |
| Bruker BioSpin GmbH & Co. KG | 5 | 2007–2023 |
From the recorded awards · regular winners know this buyer's requirements — that is your competition.
How often this buyer tenders this kind of work
5
2021
3
2023
18
2024
6
2025
1
2026
33 procedures in this category since 2019. Public procurement repeats itself — those who know the rhythm prepare instead of reacting.
·
Deadline — Monday 7 December at 10:00
Tactics
When this buyer has awarded in this sector, usually only one or two bids came in. A solid bid has a real chance here. (Based on 10 completed awards — not a statement about this procedure.)
This procedure allows 41 days between publication and deadline — typical in this country is 32 (median of 20,496 procedures). Much more generous than usual — time for a thorough bid rather than a quick one.
The deadline falls on a Monday — your last full working day is the Friday before. Have evidence and guarantees together by Thursday.
Foreign bidders
In Germany · R&D services, 161 contracts went to foreign companies over the last 3 years (of 4,002 recorded awards) — mostly from Netherlands, Italy, Spain.
Submission language: German.
Measured from linked award data; foreign winners bidding through a local subsidiary count as domestic — the true share is higher.
How to bid
Read the full notice — Original + documents
Goes directly to this tender on TED — Tenders Electronic Daily. The full specification and all annexes are there.
This procedure is published on 2 portals
All known sources are notice services. The buyer names the submission point in the notice itself.
TEDNoticeÖffentliche Vergabe (Datenservice)Notice
Put together the evidence — in German
The 13 criteria on the left, plus your price.
Submit via TED — Tenders Electronic Daily before the deadline
Electronic submission — allow time for the portal registration the first time.
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