---
title: "Qualified Person Certification of Advanced Therapy Medicinal Products"
ocid: "ocds-h6vhtk-077b6e"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-077b6e"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-077b6e.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-077b6e.json"
source: "Find A Tender Service"
current_stage: "Award"
buyer: "Guy's and St Thomas' NHS Foundation Trust"
published: "2026-09-28"
---

# Qualified Person Certification of Advanced Therapy Medicinal Products

Buyer: Guy's and St Thomas' NHS Foundation Trust  
Current stage: Award  
OCID: ocds-h6vhtk-077b6e

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## Summary

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.

## Notice

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.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/091382-2026 |
| 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 |
| All stages | Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 28 Sep 2026 |
| Submission deadline | Not specified |
| Future notice date | Not specified |
| Award date | Not specified |
| Contract period | 12 Oct 2026 - 4 Oct 2031 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | £100,250 |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Complete |
| Awards status | Pending |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | Guy's and St Thomas' NHS Foundation Trust |
| Locality | LONDON |
| Postcode area | South East London |
| Postcode | SE1 9RT |
| Country | England |
| ITL 1 | TLI London |
| ITL 2 | TLI4 Inner London - East |
| ITL 3 | TLI44 Lewisham and Southwark |
| Local authority | Southwark |
| Electoral ward | London Bridge & West Bermondsey |
| Westminster constituency | Bermondsey and Old Southwark |
| Delivery location | Not specified |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | eXmoor Pharma Concepts Limited |

## CPV Codes

### Divisions

- 73 - Research and development services and related consultancy services

### Codes

- 73200000 - Research and development consultancy services

## Release History

- 28 Sep 2026 at 12:14 - AwardUpdate - UK5 - Transparency Notice - https://www.find-tender.service.gov.uk/Notice/091382-2026
- 28 Sep 2026 at 12:09 - Award - UK5 - Transparency Notice - https://www.find-tender.service.gov.uk/Notice/091381-2026

## Documents

- https://www.find-tender.service.gov.uk/Notice/091382-2026
  28th September 2026 - Transparency notice on Find a Tender
- https://www.find-tender.service.gov.uk/Notice/091381-2026
  28th September 2026 - Transparency notice on Find a Tender

## Notice URLs

- https://www.guysandstthomas.nhs.uk
- https://www.legislation.gov.uk/ukpga/2023/54/contents

## 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-077b6e. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-077b6e.json.