✓Tender information last checkedLast checked 8 Oct 2026, 08:11.
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 engagement.
Classification
CPV85149000 — Pharmacy services
Lots
Lot 1Value not stated
Documents and notices
Preliminary market engagement notice on Find a TenderOpen source ↗
Published notice details
Additional information from the published procurement release. Fields appear only when supplied by the source; check the original notice and tender documents before acting.
NHS Blood and Transplant, NHSBT, is undertaking preliminary market engagement in connection with a proposed procurement for the provision of Qualified Person, QP, services for Investigational Medicinal Products, IMPs.
NHSBT is seeking to understand the capability, capacity and interest available within the market to provide suitably qualified and experienced QP support for its active portfolio of IMP manufacturing projects.
The proposed service may include:
Reviewing and providing regulatory and quality input into selected regulatory submissions, as requested by NHSBT.
Advising on applicable regulatory, Good Manufacturing Practice, GMP, and quality-compliance requirements for biological and Advanced Therapy Medicinal Product, ATMP, manufacturing projects.
Providing regulatory, GMP and quality input into the design and development of selected manufacturing processes and facilities.
Reviewing assigned batches and, where satisfied that all applicable legal, regulatory, GMP, Clinical Trial Authorisation, Product Specification File and NHSBT quality-system requirements have been met, certifying the batches for use in approved clinical trials.
Providing advice and guidance relating to the manufacture, certification and release of IMP batches.
Supporting NHSBT with the interpretation and application of relevant regulatory and quality requirements.
Mentoring selected NHSBT staff through the process of obtaining Qualified Person registration.
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 United Kingdom.
The supplier may be required to provide supporting evidence of the proposed Qualified Person’s qualifications, professional eligibility, regulatory status and relevant experience.
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);
reviewing and certifying IMP batches;
applying UK regulatory, GMP and quality requirements;
supporting biological and biotechnology medicinal-product manufacturing;
supporting cell therapy and gene therapy medicinal products; and
working with complex IMP manufacturing projects and associated quality systems.
The current anticipated level of support is approximately 24 to 48 days per year. NHSBT currently anticipates that at least 50% of the required support will be delivered on NHSBT premises, with the remaining support delivered remotely by agreement.
The final scope, service-delivery arrangements, volume of activity and contract requirements may be refined following the preliminary market engagement exercise.
The current contract ends on 30 June 2027. NHSBT intends to have the replacement contractual arrangement in place by 31 March 2027 to support an appropriate transition period.
Due
6 Nov 2026, 23:59
Status
scheduled
Documents
Entry 1
Id
094795-2026
Document Type
marketEngagementNotice
Notice Type
UK2
Description
Preliminary market engagement notice on Find a Tender
1 published notice version reviewed by ProcuraAxis.
1 VERSION
1
094795-2026Preliminary market engagement notice on Find a Tender ·
PROCURAAXIS ANALYSIS
ProcuraAxis Analysis
Our approved analysis of the opportunity appears below the official tender information.
ANALYSIS PREVIEW
Opportunity intelligence at a glance
Early-stage market engagement for Qualified Person (QP) services supporting NHS Blood and Transplant investigational medicinal product (IMP) manufacturing projects. The eventual service is expected to cover regulatory, GMP and quality advice, IMP batch certification, and QP mentoring.
Who this may suit
Suitable for suppliers able to provide UK IMP Qualified Persons with current required professional/regulatory status, recent named-QP experience on a UK MIA(IMP), and IMP batch-certification experience. Biological, biotechnology, cell-therapy and gene-therapy experience may be required.
Key points identified
Named QP experienceRecent, demonstrable experience acting as a named Qualified Person on a UK Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP)).Evidence: “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)”
Advanced therapy and biological product experienceExperience relating to biological, biotechnology, cell therapy and gene therapy medicinal products may be required.Evidence: “Experience relating to biological, biotechnology, cell therapy and gene therapy medicinal products may also be required.”
93% approved-analysis confidence6 supplier criteria identified3 risks or unknowns
ProcuraAxis structures information found in published procurement records, checks the result for consistency and publishes only approved analysis. Confidence describes the completeness and consistency of the available source information; it is not a guarantee of eligibility or contract award.
Early-stage market engagement for Qualified Person (QP) services supporting NHS Blood and Transplant investigational medicinal product (IMP) manufacturing projects. The eventual service is expected to cover regulatory, GMP and quality advice, IMP batch certification, and QP mentoring.
Who this may suit
Suitable for suppliers able to provide UK IMP Qualified Persons with current required professional/regulatory status, recent named-QP experience on a UK MIA(IMP), and IMP batch-certification experience. Biological, biotechnology, cell-therapy and gene-therapy experience may be required.
Key deliverables
Regulatory, GMP and quality input
Review and certification of eligible IMP batches for clinical trials
Advice on manufacturing processes and facilities
Mentoring for NHSBT staff pursuing QP registration
Professional, regulatory and quality advice
SUPPLIER REQUIREMENTS
6 criteria identified
UK Qualified Person (QP) professional eligibility and regulatory status for Investigational Medicinal Products
93% confidence
Mandatory · 1
View supporting evidence
“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.”
Named QP experience
96% confidence
Recent, demonstrable experience acting as a named Qualified Person on a UK Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP)).
View supporting evidence
“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)”
IMP batch certification experience
96% confidence
Experience certifying IMP batches.
View supporting evidence
“and of certifying IMP batches.”
Advanced therapy and biological product experience
91% confidence
Experience relating to biological, biotechnology, cell therapy and gene therapy medicinal products may be required.
View supporting evidence
“Experience relating to biological, biotechnology, cell therapy and gene therapy medicinal products may also be required.”
QP legal and regulatory standing
93% confidence
Each proposed QP must maintain the qualifications, professional eligibility and regulatory status required to act in the UK for IMPs.
View supporting evidence
“hold and maintain the qualifications, professional eligibility and regulatory status required to act as a Qualified Person for Investigational Medicinal Products in the UK.”
Other supplier eligibility requirements
95% confidence
Unknown at this market-engagement stage.
View supporting evidence
The notice gives indicative scope only and does not state further supplier eligibility criteria.
COMMERCIAL AND DELIVERY
Contract intelligence
Commercial
Published maximum value
84% confidence
Up to GBP 216,000.
View supporting evidence
Opportunity value_max: 216000 GBP.
Expected annual support volume
93% confidence
Approximately 24 to 48 days per year.
View supporting evidence
“The current anticipated level of support is approximately 24 to 48 days per year”
Pricing and contract terms
98% confidence
Unknown.
View supporting evidence
No pricing mechanism, contract duration or detailed commercial terms are stated in this preliminary market engagement notice.
Delivery
Delivery model
95% confidence
At least 50% of support is anticipated on NHSBT premises, with the remainder delivered remotely, subject to agreement.
View supporting evidence
“with at least 50% of the support delivered on NHSBT premises and the remaining support delivered remotely, subject to agreement.”
Buyer location
90% confidence
Bristol, United Kingdom (buyer location).
View supporting evidence
Location record: Bristol, BS34 7QH, United Kingdom.
Service scope
95% confidence
QP support for NHSBT IMP manufacturing projects, including regulatory, GMP, quality, batch-certification and mentoring activities.
View supporting evidence
The notice lists regulatory and quality input, GMP advice, process/facility input, batch certification, mentoring and associated advice.
PROCEDURE
How to respond
Procurement status
99% confidence
Upcoming early-stage preliminary market engagement; this is not an open bidding opportunity.
View supporting evidence
display_status: upcoming; stage: planning; notice type: “Preliminary market engagement notice on Find a Tender”.
Procurement route
99% confidence
Unknown.
View supporting evidence
procurement_method is not stated.
Scope finalisation
98% confidence
Indicative scope and requirements may be refined after preliminary market engagement.
View supporting evidence
“The scope and requirements described in this notice are indicative and may be refined following preliminary market engagement.”
Submission deadline
99% confidence
Unknown.
View supporting evidence
No submission deadline is supplied.
RISKS AND UNKNOWNS
Points requiring attention
Indicative scope
98% confidence
The service scope and requirements may change following market engagement.
View supporting evidence
“The scope and requirements described in this notice are indicative and may be refined following preliminary market engagement.”
Future competition details
98% confidence
Procurement route, timetable, submission requirements, contract term and final commercial model are unknown at this early stage.
View supporting evidence
The notice is a planning-stage preliminary market engagement notice and does not state these details.
Specialist personnel availability
94% confidence
Delivery depends on QPs holding and maintaining the required UK IMP qualifications, eligibility and regulatory status, with relevant recent MIA(IMP) and batch-certification experience.
View supporting evidence
The notice specifies these expectations for each proposed QP.
ProcuraAxis analysis supplements, but does not replace, the original notice and tender documents. Always verify eligibility, deadlines and commercial terms with the issuing authority.
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