NUIG/CON246/2021 - Qualified Person (QP) Service to CCMI - Single Party Framework

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. A Single Party Framework Agreement for the provision of QP Services will be established for an initial period of two years, with the option to extend for 2 years, each awarded separately, to a maximum duration of 4 years, subject to satisfactory performance, business needs and budgetary constraints.

Services

15/11/2021 16:00:00

85120000-6  Medical practice and related services
73111000-3  Research laboratory services
85121000-3  Medical practice services
85121200-5  Medical specialist services
85148000-8  Medical analysis services