Non-Clinical Toxicology and safety assessment of a small molecule

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)

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)

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)

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)

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).

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)

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)

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)

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)

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)

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)

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)

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)