II.1)
[QuantityScopeContract]
Qualified Person (QP) Service to CCMI - Single Party Framework
[Fileref]:
NUIG/CON246/2021
[Services]
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)
[ValueMagnitudeEstimatedTotal]
[ValueExclVat]: 360000.00
EUR
[DivisionLots]:
[No]
73111000
-
85121000
-
85121200
-
85148000
-
II.2.3)
[PlacePerformance]
[MainsiteplaceWorksDelivery]:
Galway
II.2.4)
[DescrProcurement]
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.
[AwardCriteriaDescriptive]
II.2.6)
[ValueMagnitudeEstimated]
[ValueExclVat]: 360000.00
EUR
II.2.7)
[DurationContractFrameworkDps]
[DurationMonths]:
24
[RenewalsSubject]:
[Yes]
[RenewalsDescr]:
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.
[VariantsAccepted]:
[No]
[Options]:
[No]
[EuProgrRelated]:
[No]