Regulatory, Technical and manufacturing support for a diagnostic test

The University is seeking expressions of interest from suppliers who can provide Regulatory, manufacturing and technical support to the NEOSEPSIS project for the purpose of making a competitive serum amyloid A (SAA) lateral flow test available as a sepsis diagnostic in Uganda and Low-Middle Income countries to prevent neonatal and …

CPV: 71900000 Лабораторни услуги, 73111000 Научни изследвания в областта на естествените, медицинските, селскостопанските и техническите науки
Място на изпълнение:
Regulatory, Technical and manufacturing support for a diagnostic test
Издаващ орган:
Maynooth University
Номер на наградата:
0

1. Buyer

1.1 Buyer

Official name : Maynooth University
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Education

2. Procedure

2.1 Procedure

Title : Regulatory, Technical and manufacturing support for a diagnostic test
Description : The University is seeking expressions of interest from suppliers who can provide Regulatory, manufacturing and technical support to the NEOSEPSIS project for the purpose of making a competitive serum amyloid A (SAA) lateral flow test available as a sepsis diagnostic in Uganda and Low-Middle Income countries to prevent neonatal and maternal deaths. The NEOSEPSIS project proposes to use the NeoSep SAA test to reduce neonatal and maternal mortality by rapid detection of sepsis in Low-Middle Income Countries. This solution will be delivered by implementing the test in hospitals, health facilities and non-hospital environments in Uganda for the rapid detection of neonatal and maternal sepsis. At present, clinical evaluations have been completed to evaluate the performance of the NeoSep SAA test in both hospital and non-hospital settings. Statistical analysis of data collected, clearly indicates that the test has proved successful in both settings and the results have been published. The next key steps for deployment of the solution, which are underway, is to undertake essential extra clinical evaluations in Uganda, progress the registration of the NeoSep SAA test in Uganda, implement a process for manufacturing and supply of the NeoSep-SAA kit and develop a clear plan for supply and distribution of the test initially into the Ugandan market. Qualifications and Previous Experience: Applicant companies must have a Quality Management System in place (e.g., ISO9000). Applicant companies must have experience in development, manufacture and supply of competitive lateral flow tests to detect human serum amyloid A. Applicant companies must be capable of supporting technology transfer of lateral flow test systems. Ideally, applicant companies should be able to demonstrate adaptation of lateral flow tests for quantitative analyte detection.
Procedure identifier : 41b6797b-c751-4d6d-9886-cb1e663111cb
Type of procedure : Restricted

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73111000 Research laboratory services
Additional classification ( cpv ): 71900000 Laboratory services

2.1.2 Place of performance

Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Additional information : see tender document

2.1.3 Value

Estimated value excluding VAT : 130 000 Euro

2.1.4 General information

Legal basis :
Directive 2014/24/EU

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Regulatory, Technical and manufacturing support for a diagnostic test
Description : The University is seeking expressions of interest from suppliers who can provide Regulatory, manufacturing and technical support to the NEOSEPSIS project for the purpose of making a competitive serum amyloid A (SAA) lateral flow test available as a sepsis diagnostic in Uganda and Low-Middle Income countries to prevent neonatal and maternal deaths. The NEOSEPSIS project proposes to use the NeoSep SAA test to reduce neonatal and maternal mortality by rapid detection of sepsis in Low-Middle Income Countries. This solution will be delivered by implementing the test in hospitals, health facilities and non-hospital environments in Uganda for the rapid detection of neonatal and maternal sepsis. At present, clinical evaluations have been completed to evaluate the performance of the NeoSep SAA test in both hospital and non-hospital settings. Statistical analysis of data collected, clearly indicates that the test has proved successful in both settings and the results have been published. The next key steps for deployment of the solution, which are underway, is to undertake essential extra clinical evaluations in Uganda, progress the registration of the NeoSep SAA test in Uganda, implement a process for manufacturing and supply of the NeoSep-SAA kit and develop a clear plan for supply and distribution of the test initially into the Ugandan market. Qualifications and Previous Experience: Applicant companies must have a Quality Management System in place (e.g., ISO9000). Applicant companies must have experience in development, manufacture and supply of competitive lateral flow tests to detect human serum amyloid A. Applicant companies must be capable of supporting technology transfer of lateral flow test systems. Ideally, applicant companies should be able to demonstrate adaptation of lateral flow tests for quantitative analyte detection.
Internal identifier : 0

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73111000 Research laboratory services
Additional classification ( cpv ): 71900000 Laboratory services

5.1.2 Place of performance

Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Additional information :

5.1.3 Estimated duration

Other duration : Unknown

5.1.5 Value

Estimated value excluding VAT : 130 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : English
Languages in which the procurement documents (or their parts) are unofficially available : English

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Tenderers may submit more than one tender : Not allowed
Deadline for receipt of expressions of interest : 13/08/2025 12:00 +01:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : The High Court of Ireland
Information about review deadlines : see tender documents
Organisation providing additional information about the procurement procedure : Maynooth University
Organisation providing offline access to the procurement documents : Maynooth University
Organisation receiving requests to participate : Maynooth University
Organisation processing tenders : Maynooth University

8. Organisations

8.1 ORG-0001

Official name : Maynooth University
Registration number : 2163
Postal address : Maynooth University
Town : Maynooth
Postcode : W23
Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Telephone : +14747679
Roles of this organisation :
Buyer
Organisation providing additional information about the procurement procedure
Organisation providing offline access to the procurement documents
Organisation receiving requests to participate
Organisation processing tenders

8.1 ORG-0002

Official name : The High Court of Ireland
Registration number : The High Court of Ireland
Department : The High Court of Ireland
Postal address : Four Courts, Inns Quay, Dublin 7
Town : Dublin
Postcode : D07 WDX8
Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Telephone : +353 1 8886000
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Dynamics S.A.
Registration number : 002024901000
Department : European Dynamics S.A.
Town : Athens
Postcode : 15125
Country subdivision (NUTS) : Βόρειος Τομέας Αθηνών ( EL301 )
Country : Greece
Telephone : +30 2108094500
Roles of this organisation :
TED eSender

Notice information

Notice identifier/version : 51407ba0-9d52-4470-a8c1-6be0050ce804 - 01
Form type : Competition
Notice type : Prior information notice or a periodic indicative notice used as a call for competition – standard regime
Notice dispatch date : 08/07/2025 10:37 +01:00
Languages in which this notice is officially available : English
Notice publication number : 00446581-2025
OJ S issue number : 129/2025
Publication date : 09/07/2025