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.
Deadline
The time limit for receipt of tenders was 2021-11-15.
The procurement was published on 2021-10-12.
Object Scope of the procurement
Title: Qualified Person (QP) Service to CCMI - Single Party Framework
NUIG/CON246/2021
Products/services: Medical practice and related services📦
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....”
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.
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Estimated value excluding VAT: EUR 360 000 💰
1️⃣
Additional products/services: Research laboratory services📦
Additional products/services: Medical practice services📦
Additional products/services: Medical specialist services📦
Additional products/services: Medical analysis services📦
Place of performance: West🏙️
Main site or place of performance: Galway
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...”
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.
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Price is not the only award criterion and all criteria are stated only in the procurement documents
Scope of the procurement
Estimated total value excluding VAT: EUR 360 000 💰
Duration of the contract, framework agreement or dynamic purchasing system
The time frame below is expressed in number of months.
Description
Duration: 24
Duration of the contract, framework agreement or dynamic purchasing system
This contract is subject to renewal ✅ Description
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...”
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.
Legal, economic, financial and technical information Economic and financial standing
Selection criteria as stated in the procurement documents
Technical and professional ability
Selection criteria as stated in the procurement documents
Procedure Type of procedure
Open procedure
Information about a framework agreement or a dynamic purchasing system
Framework agreement with a single operator
Administrative information
Time limit for receipt of tenders or requests to participate: 2021-11-15
16:00 📅
Languages in which tenders or requests to participate may be submitted: English 🗣️
Conditions for opening of tenders: 2021-11-15
16:00 📅
Complementary information Information about recurrence
This is a recurrent procurement ✅
Estimated timing for further notices to be published: 2025
Information about electronic workflows
Electronic invoicing will be accepted
Electronic payment will be used
Review body
Name: Central Office of the HIgh Court
Postal address: Inns Quay
Postal town: Dublin
Postal code: 7
Country: Ireland 🇮🇪
Source: OJS 2021/S 201-524511 (2021-10-12)
Contract award notice (2022-02-04) Object Scope of the procurement
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...”
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.
Show more Description
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...”
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.
Show more Award criteria
Quality criterion (name): Understanding of Brief and Proposed Methodology
Quality criterion (weighting): 30
Quality criterion (name): Quality of Team Proposed and Continuity of Service
Quality criterion (weighting): 25
Quality criterion (name): Contract Management
Quality criterion (weighting): 10
Price (weighting): 35
Procedure Information about framework agreement
The procurement involves the establishment of a framework agreement
Administrative information
Previous publication concerning this procedure: 2021/S 201-524511
Award of contract
1️⃣
Contract Number: 1
Title: Qualified Person (QP) Service to CCMI
Information on non-award
No tenders or requests to participate were received or all were rejected
Source: OJS 2022/S 028-072224 (2022-02-04)