II.1)
Scope of the procurement
Qualified Person (QP) Service to CCMI - Single Party Framework
Reference number:
NUIG/CON246/2021
85120000
-
Medical practice and related services
Services
II.1.4)
Short description
CANCELLATION NOTICE: 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.1.6)
Information about lots
This contract is divided into lots:
no
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
Main site or place of performance:
Galway
II.2.4)
Description of the procurement
CANCELLATION NOTICE: 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.
Criteria below
Quality criterion
-
Name:
Understanding of Brief and Proposed Methodology
/
Weighting:
30
Quality criterion
-
Name:
Quality of Team Proposed and Continuity of Service
/
Weighting:
25
Quality criterion
-
Name:
Contract Management
/
Weighting:
10
Price
-
Weighting:
35
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