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Qualified Person Certification of Advanced Therapy Medicinal Products

Guy's and St Thomas' NHS Foundation Trust

This public procurement record has 2 releases in its history.

AwardUpdate

28 Sep 2026 at 12:14

UK5 - Transparency Notice
Award

28 Sep 2026 at 12:09

UK5 - Transparency Notice
Summary of the contracting process

Guy’s and St Thomas’ NHS Foundation Trust procured a Qualified Person service to certify Advanced Therapy Medicinal Products (ATMPs) for patients enrolled in clinical trials. The work supports compliance with the Medicines and Healthcare products Regulatory Agency (MHRA) licence and other legal and regulatory obligations, including certification and release of medicinal products for clinical use. It covers specialist oversight of manufacturing activities, deviations, investigations, quality decisions and batch certification, with particular relevance to T-reg and CAR-T reg manufacturing. This is a specialist pharmaceutical quality and regulatory service rather than the supply of medicines or general research consultancy. The buyer is Guy’s and St Thomas’ NHS Foundation Trust, and the service supports the Trust’s clinical-trial activity in London.

The procurement is complete and was awarded by direct award to eXmoor Pharma Concepts Limited. The award is recorded as pending; the contract is due to start on 12 October 2026 and run to 4 October 2031. Its awarded value is £100,250 excluding VAT (£120,300 including VAT). The Trust may renew for a year at a time, for up to four years, depending on service quality, funding availability and clinical needs. The direct award was justified on technical grounds: the supplier’s specialist ATMP expertise and specific familiarity with T-reg and CAR-T reg manufacturing were considered difficult to replace, and retaining that knowledge was intended to support regulatory compliance and reduce disruption. The requirement was a single lot, identified as suitable for SMEs.

This award demonstrates demand for a highly specialised Qualified Person service supporting clinical-trial ATMP manufacturing and product release. Suppliers competing for a comparable requirement would need to show relevant Qualified Person capability alongside demonstrable experience with advanced therapies, and product- and process-specific knowledge, particularly in T-reg and CAR-T reg manufacturing. Credibility would depend on being able to assess manufacturing, deviations, investigations and quality decisions, and to certify batches while maintaining compliance with MHRA licensing and applicable regulation. The Trust’s stated rationale highlights the commercial value of continuity and familiarity with its manufacturing process: a new provider would need to show how it could assume responsibility without a lengthy learning period or disruption to manufacturing capacity and patient supply. The procurement was considered suitable for SMEs, indicating that a specialist provider need not necessarily be a large supplier.

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Notice Information

Notice Title

Qualified Person Certification of Advanced Therapy Medicinal Products

Notice Description

Guy's and St Thomas' NHS Foundation Trust requires a Qualified Person service to certify Advanced Therapy Medicinal Products for patients enrolled in clinical trials. The service will ensure compliance with the requirements of the MHRA licence and all applicable legal and regulatory obligations, enabling the certification and release of medicinal products for clinical use.

Procurement Information

The following rationale supports the proposed direct award under Schedule 5 of the Procurement Act 2023 on the grounds of technical reasons. Exmoor Pharma QP brings specialist expertise in advanced therapies medicinal products, together with direct and extensive familiarity with T-reg and CAR-T reg manufacturing. This combination of advanced therapy experience and product-specific knowledge is highly specialised and is unlikely to be readily available from another QP. Such familiarity provides significant value in the assessment and oversight of manufacturing activities, deviations, investigations, quality decisions, and batch certification, where an understanding of the specific product, process and associated risks is essential. Retaining this expertise therefore provides both a regulatory and operational benefit. It supports continued GMP compliance while avoiding the potentially lengthy learning period associated with transferring responsibility to a new QP who has no prior experience of the organisation or T-reg manufacturing process. It also reduces the risk of disruption to manufacturing activities and the consequential impact on production capacity and patient supply. Guy's and St Thomas' NHS Foundation Trust is relying on Section 41 and Paragraph 6(a) and 7(b) of Schedule 5 of the Procurement Act 2023 to justify the use of direct award in special cases.

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-077b6e
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/091382-2026
Current Stage
Award
All Stages
Award

Procurement Classification

Notice Type
UK5 - Transparency Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Direct
Procurement Method Details
Direct award
Tender Suitability
SME
Awardee Scale
SME

Common Procurement Vocabulary (CPV)

CPV Divisions

73 - Research and development services and related consultancy services

CPV Codes

73200000 - Research and development consultancy services

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
£100,250 £100K-£500K
Contracts Value
Not specified

Notice Dates

Publication Date
28 Sep 20261 weeks ago
Submission Deadline
Not specified
Future Notice Date
Not specified
Award Date
Not specified
Contract Period
12 Oct 2026 - 4 Oct 2031 4-5 years
Recurrence
Not specified

Notice Status

Tender Status
Complete
Lots Status
Complete
Awards Status
Pending
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
Guy's and St Thomas' NHS Foundation Trust
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
LONDON
Postcode
SE1 9RT
Postcode Area
South East London
Country
England
Major Region (ITL 1)
TLI London
Basic Region (ITL 2)
TLI4 Inner London - East
Small Region (ITL 3)
TLI44 Lewisham and Southwark
Delivery Location
Not specified
Local Authority
Southwark
Electoral Ward
London Bridge & West Bermondsey
Westminster Constituency
Bermondsey and Old Southwark

Supplier Information

Number of Suppliers
1
Supplier Name

eXmoor Pharma Concepts Limited

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.

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