---
title: "Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: \"Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision\""
ocid: "ocds-kuma6s-147495"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-kuma6s-147495"
markdown_url: "https://d3tenders.com/contract/ocds-kuma6s-147495.md"
json_url: "https://d3tenders.com/contract/ocds-kuma6s-147495.json"
source: "Sell2Wales"
current_stage: "Award"
buyer: "NHS WALES SHARED SERVICES PARTNERSHIP (NWSSP) - PROCUREMENT SERVICES"
published: "2025-01-20"
---

# Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision"

Buyer: NHS WALES SHARED SERVICES PARTNERSHIP (NWSSP) - PROCUREMENT SERVICES  
Current stage: Award  
OCID: ocds-kuma6s-147495

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## Summary

The NHS Wales Shared Services Partnership (NWSSP) - Procurement Services, located in Cardiff, has awarded a contract for the supply and manufacture of Investigational Medicinal Products (IMPs) needed for a clinical trial titled "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision." This clinical trial is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme. The procurement method was limited, as the products involved are manufactured purely for research purposes. The contract was awarded to Simbec Research Limited, based in Merthyr Tydfil, and has been effective since 1st January 2025, with a contract value of GBP 116,645.

This tender presents significant opportunities for businesses involved in the research, manufacture, and regulatory compliance of medicinal products, particularly within the health sector. SMEs and specialised pharmaceutical manufacturers like Simbec Research Limited, which possess the unique capabilities required for such clinical trials, would find this procurement process well-suited for their participation. Companies that can handle tasks such as product encapsulation, packaging, labelling, quality assurance certification, and storage and shipment logistics are essential for meeting the stringent requirements and regulatory compliance associated with clinical trials.

## Notice

Cardiff and Vale University Health Board (CAVUHB) is undertaking a clinical trial entitled 'Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision', funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (Ref: NIHR 160872). As part of this clinical trial, an Investigational Medicinal Product (IMP) needs to be manufactured and distributed.

### Lot Information

Lot 1

Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision" Cardiff and Vale University Health Board (CAVUHB) is undertaking a clinical trial entitled 'Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision', funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (Ref: NIHR 160872). As part of this clinical trial, an Investigational Medicinal Product (IMP) needs to be manufactured and distributed. The IMPs required are: -Flucloxacillin 2 x 500mg capsules, over encapsulated -A matching placebo of inert filler, over encapsulated to match flucloxacillin 2 x 500mg capsules. The successful supplier will be responsible for the manufacture, packaging, labelling, Quality Assurance (QA) certification, storage, shipment, and regulatory compliance (CTIMP regulations) associated with the trial's IMPs. After extensive market research and consultations with multiple suppliers, it has been concluded that only one supplier, Simbec-Orion, has the capability to fulfil the full scope of the contract requirements. This includes: -Over encapsulation of flucloxacillin and matching placebo -Packaging and labelling of the final product -Compliance with clinical trial regulations (CTIMP) -Storage and shipment logistics to participating NHS sites -QA certification and regulatory compliance for blinded clinical trials Simbec-Orion will also source the bulk IMP (4 lots of flucloxacillin, 1 lot of placebos), over encapsulate the product, and ensure all necessary documentation and quality assurance procedures are met. Simbec-Orion is uniquely positioned to meet the requirements of the clinical trial due to its established capabilities in the manufacture and regulatory compliance of Investigational Medicinal Products (IMPs). No other supplier was found to be able to offer the complete set of services required for this project.

### Procurement Information

The products involved are manufactured purely for the purpose of research. In addition, Simbec-Orion is positioned to meet the requirements of the clinical trial. No other supplier was found to be able to offer the complete set of services required for this project.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Sell2Wales |
| Latest notice | https://www.sell2wales.gov.wales/search/search_switch.aspx?ID=147495 |
| Notice type | OJEU - F15 - Voluntary Ex Ante Transparency Notice |
| Procurement type | Standard |
| Procurement category | Goods |
| Procurement method | Limited |
| Procurement method details | Award procedure without prior publication of a call for competition |
| Tender suitability | Not specified |
| Awardee scale | SME |
| All stages | Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 20 Jan 2025 |
| Submission deadline | Not specified |
| Future notice date | Not specified |
| Award date | 1 Jan 2025 |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | £116,645 |

## Status

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

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | NHS WALES SHARED SERVICES PARTNERSHIP (NWSSP) - PROCUREMENT SERVICES |
| Locality | CARDIFF |
| Post town | Cardiff |
| Postcode | CF14 4HH |
| Country | Wales |
| ITL 1 | TLL Wales |
| ITL 2 | TLL5 South East Wales |
| ITL 3 | TLL52 Cardiff and Vale of Glamorgan |
| Local authority | Cardiff |
| Electoral ward | Heath |
| Westminster constituency | Cardiff North |
| Delivery location | TLL22 Cardiff and Vale of Glamorgan |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | SIMBEC RESEARCH |

## CPV Codes

### Divisions

- 33 - Medical equipments, pharmaceuticals and personal care products

### Codes

- 33000000 - Medical equipments, pharmaceuticals and personal care products

## Release History

- 20 Jan 2025 at 00:00 - Award - OJEU - F15 - Voluntary Ex Ante Transparency Notice - https://www.sell2wales.gov.wales/search/search_switch.aspx?ID=147495

## Documents

- https://www.sell2wales.gov.wales/search/show/search_view.aspx?ID=JAN497192
  Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision" - Cardiff and Vale University Health Board (CAVUHB) is undertaking a clinical trial entitled 'Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision', funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (Ref: NIHR 160872). As part of this clinical trial, an Investigational Medicinal Product (IMP) needs to be manufactured and distributed.

## Notice URLs

- http://nwssp.nhs.wales/ourservices/procurement-services/
- http://www.sell2wales.gov.wales/Search/Search_Switch.aspx?ID=147495
- https://api.sell2wales.gov.wales/v1?lang=cy/Notice?id=ocds-kuma6s-147495

## 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-kuma6s-147495. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-kuma6s-147495.json.