CMNHS246/2026- Establishment of a Single Operator Framework Agreement For Qualified Person (QP) Services to CCMI for the University of Galway

CMNHS246/2026- Establishment of a Single Operator Framework Agreement For Qualified Person (QP) Services to CCMI for the University of Galway

University of Galway (ID 1400)

## Summary The University of Galway is procuring a Qualified Person (QP) service for the Centre for Cell Manufacturing Ireland (CCMI). The QP will review batch documentation relating to the manufacture of ATMP Products for Clinical Trials. This tender is for a single operator framework agreement.

## Scope & Deliverables * Review batch documentation related to the manufacture of ATMP Products for Clinical Trials * Release products for administration to Clinical Trial Patients in accordance with relevant requirements

## Key Requirements * Eligibility: Not stated * Qualifications: + Qualified Person (QP) certification + Relevant experience in reviewing batch documentation and releasing products for clinical trials * Certifications: Qualified Person (QP) certification * Experience: Relevant experience in reviewing batch documentation and releasing products for clinical trials

## Commercials & Timeline * Estimated value: €300,000 * Submission deadline: Thu Sep 10 12:00:00 IST 2026 * Contract duration: 4 months * Framework agreement: Yes, without reopening of competition

## How to Bid * Submission method: Electronic submission required through etenders.gov.ie * Languages: English * Key documents to prepare: + Tender submission + Qualifications and experience documentation + Proof of QP certification

## Bid Considerations * This tender may suit companies with relevant experience in reviewing batch documentation and releasing products for clinical trials. * Opportunities: + Potential for long-term contract due to framework agreement + Opportunity to work with a reputable university and research institution * Risks: + High competition due to open procedure + Complex requirements and qualifications

Open procedure. Any interested supplier may submit a tender. There is no shortlisting stage — all compliant bids received by the deadline are evaluated against the published award criteria. It is the most common route for Irish public contracts and is open to SMEs and new entrants.

University of Galway (ID 1400) has 74 tender(s) tracked on TenderScout, of which 1 are currently open. On the EU TED record this buyer has awarded 179 contract(s) worth around €164,609,233.

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