--- title: "Qualified Person Service for Investigational Medicinal Products (IMP)" ocid: "ocds-h6vhtk-0782d2" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-0782d2" markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-0782d2.md" json_url: "https://d3tenders.com/contract/ocds-h6vhtk-0782d2.json" source: "Find A Tender Service" current_stage: "Planning" buyer: "NHS Blood and Transplant" published: "2026-10-07" --- # Qualified Person Service for Investigational Medicinal Products (IMP) Buyer: NHS Blood and Transplant Current stage: Planning OCID: ocds-h6vhtk-0782d2 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-0782d2) [Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-0782d2.json) ## Summary NHS Blood and Transplant plans to procure Qualified Person services for its portfolio of Investigational Medicinal Product manufacturing projects. The work may cover regulatory and quality input to submissions; advice on UK regulatory, Good Manufacturing Practice and quality requirements for biological and advanced therapy medicinal products; input to manufacturing processes and facilities; and review and certification of batches for approved clinical trials. The supplier may also advise on manufacture, certification and release, help NHSBT apply relevant requirements, and mentor staff seeking Qualified Person registration. This is specialist pharmaceutical quality and regulatory support, rather than general pharmacy provision. At least half of the work is expected to take place at NHSBT premises, with the remainder delivered remotely by agreement. This procurement is at the planning stage: NHSBT has set out its intention to buy the service and is conducting preliminary market engagement, not inviting tenders. NHSBT expects to publish a further notice on 4 December 2026. It anticipates having the replacement arrangement in place by 31 March 2027, ahead of the current contract ending on 30 June 2027. The expected contract period runs from 31 March 2027 to 31 March 2030, with a possible extension to 31 March 2032. The stated estimated value is £216,000 excluding VAT (£259,200 including VAT). There is one lot. The final scope, service volume and delivery arrangements may be refined after engagement; no procurement method or evaluation criteria are set out at this stage. This work is suited to specialist suppliers able to provide appropriately qualified and experienced UK Qualified Persons for Investigational Medicinal Products. Each proposed QP is expected to maintain the qualifications, professional eligibility and regulatory status needed to act in this role in the UK, and may need to provide evidence of these credentials and relevant experience. NHSBT is looking for recent, demonstrable experience acting as a named QP on a UK Manufacturing and Import Authorisation for IMPs and reviewing and certifying IMP batches. Experience with biological and biotechnology medicines, cell and gene therapies, complex manufacturing projects and associated quality systems is relevant. Suppliers should be able to provide flexible professional support, including on NHSBT premises and remotely, and potentially mentor NHSBT staff pursuing QP registration. SMEs and voluntary, community or social enterprises are considered suitable. ## Notice 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. ### Planning Information 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. ## Key Details | Field | Value | | --- | --- | | Publication source | Find A Tender Service | | Latest notice | https://www.find-tender.service.gov.uk/Notice/094795-2026 | | Notice type | UK2 - Preliminary Market Engagement Notice | | Procurement type | Standard | | Procurement category | Services | | Procurement method | Not Specified | | Procurement method details | Not specified | | Tender suitability | SME, VCSE | | Awardee scale | Not specified | | All stages | Planning | ## Dates | Field | Value | | --- | --- | | Publication date | 7 Oct 2026 | | Submission deadline | Not specified | | Future notice date | 4 Dec 2026 | | Award date | Not specified | | Contract period | 31 Mar 2027 - 31 Mar 2030 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £216,000 | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Planning | | Lots status | Planning | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | NHS Blood and Transplant | | Locality | BRISTOL | | Postcode area | Bristol | | Postcode | BS34 7QH | | Country | England | | ITL 1 | TLK South West (England) | | ITL 2 | TLK5 West of England | | ITL 3 | TLK52 Bath & North East Somerset and South Gloucestershire | | Local authority | South Gloucestershire | | Electoral ward | Filton | | Westminster constituency | Filton and Bradley Stoke | | Delivery location | Not specified | ## CPV Codes ### Divisions - 85 - Health and social work services ### Codes - 85149000 - Pharmacy services ## Release History - 7 Oct 2026 at 14:21 - Planning - UK2 - Preliminary Market Engagement Notice - https://www.find-tender.service.gov.uk/Notice/094795-2026 ## Documents - https://www.find-tender.service.gov.uk/Notice/094795-2026 7th October 2026 - Preliminary market engagement notice on Find a Tender ## Notice URLs - https://www.legislation.gov.uk/ukpga/2023/54/contents - https://www.nhsbt.nhs.uk/ ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-0782d2. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-0782d2.json.