Opportunity Overview
NHS Blood and Transplant is seeking to appoint a suitably qualified and experienced supplier to provide Qualified Person services in support of its portfolio of Investigational Medicinal Product manufacturing projects.
The proposed service may include:
reviewing and providing regulatory and quality input into selected regulatory submissions;
advising on applicable regulatory, Good Manufacturing Practice and quality-compliance requirements for biological and Advanced Therapy Medicinal Product manufacturing projects;
providing regulatory, GMP and quality input into the design and development of selected manufacturing processes and facilities;
reviewing assigned batches and, where all applicable legal, regulatory, GMP, Clinical Trial Authorisation, Product Specification File and NHSBT quality-system requirements have been met, certifying batches for use in approved clinical trials;
mentoring selected NHSBT staff undertaking the process of obtaining Qualified Person registration; and
providing associated professional, regulatory and quality advice as required.
Each Qualified Person proposed by the supplier will be expected to hold and maintain the qualifications, professional eligibility and regulatory status required to act as a Qualified Person for Investigational Medicinal Products in the UK.
Proposed personnel should have recent and demonstrable experience of acting as a named Qualified Person on a UK Manufacturing and Import Authorisation for Investigational Medicinal Products, MIA(IMP), and of certifying IMP batches. Experience relating to biological, biotechnology, cell therapy and gene therapy medicinal products may also be required.
The current anticipated level of support is approximately 24 to 48 days per year, with at least 50% of the support delivered on NHSBT premises and the remaining support delivered remotely, subject to agreement.
The scope and requirements described in this notice are indicative and may be refined following preliminary market...
The proposed service may include:
reviewing and providing regulatory and quality input into selected regulatory submissions;
advising on applicable regulatory, Good Manufacturing Practice and quality-compliance requirements for biological and Advanced Therapy Medicinal Product manufacturing projects;
providing regulatory, GMP and quality input into the design and development of selected manufacturing processes and facilities;
reviewing assigned batches and, where all applicable legal, regulatory, GMP, Clinical Trial Authorisation, Product Specification File and NHSBT quality-system requirements have been met, certifying batches for use in approved clinical trials;
mentoring selected NHSBT staff undertaking the process of obtaining Qualified Person registration; and
providing associated professional, regulatory and quality advice as required.
Each Qualified Person proposed by the supplier will be expected to hold and maintain the qualifications, professional eligibility and regulatory status required to act as a Qualified Person for Investigational Medicinal Products in the UK.
Proposed personnel should have recent and demonstrable experience of acting as a named Qualified Person on a UK Manufacturing and Import Authorisation for Investigational Medicinal Products, MIA(IMP), and of certifying IMP batches. Experience relating to biological, biotechnology, cell therapy and gene therapy medicinal products may also be required.
The current anticipated level of support is approximately 24 to 48 days per year, with at least 50% of the support delivered on NHSBT premises and the remaining support delivered remotely, subject to agreement.
The scope and requirements described in this notice are indicative and may be refined following preliminary market...
How to bid: GlobalGov tracks this tender; it does not accept bids. Submit your response through the issuing agency’s official notice.
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| Issuing agency | NHS Blood and Transplant |
|---|---|
| Country | United Kingdom |
| Category | Government Procurement |
| Estimated value | $274,320 |
| Published | October 07, 2026 |
| Procurement stage | Request for Proposal (RFP) |
| Response due | Not specified / rolling |
| Status | Open — accepting responses |
| Official source | View original notice |
| Last verified | October 12, 2026 |
Contains public sector information licensed under the Open Government Licence v3.0. Source: UK Government (Find a Tender).
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