ETENDERS

Contract notice

Information

Published

Date of dispatch of this notice: 12/10/2021

Expire date: 15/11/2021

External Reference: 2021-282304

TED Reference: 2021/S 201-524511

Contract notice

Contract notice

Directive 2014/24/EU

Section I: Contracting authority

I.1)

Name and addresses

National University of Ireland, Galway (NUI Galway)
N/A
University Road
Galway
IE
Contact person: Máire Hornibrook
Telephone: +353 91524411
E-mail: maire.hornibrook@nuigalway.ie
NUTS code:  IE042 -  West
Internet address(es):
Main address: http://www.nuigalway.ie
Address of the buyer profile: https://irl.eu-supply.com/ctm/Company/CompanyInformation/Index/414

I.3)

Communication

The procurement documents are available for unrestricted and full direct access, free of charge, at:  
http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=199694&B=ETENDERS_SIMPLE
Additional information can be obtained from
the abovementioned address:  
Tenders or requests to participate must be submitted
electronically via:  http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=199694&B=ETENDERS_SIMPLE
Tenders or requests to participate must be submitted
to the abovementioned address
I.4)

Type of the contracting authority

Body governed by public law
I.5)

Main activity

Education

Section II: Object

II.1)

Scope of the procurement

II.1.1)

Title

Qualified Person (QP) Service to CCMI - Single Party Framework
Reference number:  NUIG/CON246/2021
II.1.2)

Main CPV code

85120000  -  Medical practice and related services
II.1.3)

Type of contract

Services
II.1.4)

Short description

Establishment of a Single Party Framework for the provision of a Qualified Person (QP) Service to the Centre for Cell Manufacturing (CCMI) at NUI Galway. The Qualified Person will be required to review and certify batches relating to the manufacture of Stem Cell – ATMP Products for Clinical Trials, and related quality processes.
II.1.5)

Estimated total value

Value excluding VAT: 360000.00  EUR
II.1.6)

Information about lots

This contract is divided into lots: no
II.2)

Description

II.2.2)

Additional CPV code(s)

73111000  -  Research laboratory services
85121000  -  Medical practice services
85121200  -  Medical specialist services
85148000  -  Medical analysis services
II.2.3)

Place of performance

NUTS code:  IE042 -  West
Main site or place of performance:  
Galway
II.2.4)

Description of the procurement

The Centre for Cell Manufacturing (CCMI) at NUI Galway is the first facility on the island of Ireland to receive regulatory authorisation from the Health Products Regulatory Authority (HPRA) to manufacture Advanced Therapy Medicinal Products (ATMPs). It is affiliated with NUI Galway’s School of Medicine and serves as a key translational outlet for research carried out in NUI Galway's Regenerative Medicine Institute (REMEDI). Within this custom-built centre, the CCMI team produce stem cell products that are used in human clinical trials designed to test their effectiveness in a range of life-limiting medical conditions. CCMI require the services of a Qualified Person (QP) to review batch documentation relating to the manufacture of Stem Cell – ATMP Products for Clinical Trials.
II.2.5)

Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)

Estimated value

Value excluding VAT: 360000.00  EUR
II.2.7)

Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 24
This contract is subject to renewal: yes
Description of renewals:  
The Framework will initially be established for two years with the option to extend for an additional 12 months, on two occasions, subject to a maximum term of 4 years, subject to satisfactory performance, business needs and budgetary constraints.
II.2.10)

Information about variants

Variants will be accepted: no
II.2.11)

Information about options

Options: no
II.2.13)

Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: no

Section III: Legal, economic, financial and technical information

III.1)

Conditions for participation

III.1.2)

Economic and financial standing

Selection criteria as stated in the procurement documents
III.1.3)

Technical and professional ability

Selection criteria as stated in the procurement documents
III.2)

Conditions related to the contract

Section IV: Procedure

IV.1)

Description

IV.1.1)

Type of procedure

Open procedure
IV.1.3)

Information about a framework agreement or a dynamic purchasing system

The procurement involves the establishment of a framework agreement
Framework agreement with a single operator
IV.1.8)

Information about the Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement : yes
IV.2)

Administrative information

IV.2.2)

Time limit for receipt of tenders or requests to participate

Date:  15/11/2021
Local time:  16:00
IV.2.4)

Languages in which tenders or requests to participate may be submitted

English
IV.2.7)

Conditions for opening of tenders

Date:  15/11/2021
Local time:  16:00

Section VI: Complementary information

VI.1)

Information about recurrence

This is a recurrent procurement:  yes
Estimated timing for further notices to be published:  
2025
VI.2)

Information about electronic workflows

Electronic invoicing will be accepted
Electronic payment will be used
VI.4)

Procedures for review

VI.4.1)

Review body

Central Office of the HIgh Court
Inns Quay
Dublin
7
IE