Award

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

NHS WALES SHARED SERVICES PARTNERSHIP (NWSSP) - PROCUREMENT SERVICES

This public procurement record has 1 release in its history.

Award

20 Jan 2025 at 12:02

Summary of the contracting process

NHS Wales Shared Services Partnership (NWSSP) - Procurement Services has completed a procurement process for Cardiff and Vale University Health Board, based in Cardiff, for the supply and manufacture of Investigational Medicinal Products (IMPs) required for a clinical trial titled "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision". The industry category for this tender is medical equipment, pharmaceuticals, and personal care products. The contract, which has been awarded, involves specific tasks such as manufacturing and distributing flucloxacillin capsules and matching placebos. This procurement follows the limited procurement method, where the contract was negotiated without the publication of a notice, and Simbec-Orion has been identified as the sole supplier capable of meeting all the project requirements. The contract was signed on 1 January 2025, following a 10-day standstill period.

This tender presents significant opportunities for businesses specialising in the pharmaceutical industry, particularly those with expertise in clinical trial supplies, regulatory compliance, and Quality Assurance (QA) certification. Companies capable of handling the complex logistics of packaging, labelling, and meeting clinical trial regulatory requirements would find this contract highly beneficial. Such businesses would not only contribute to essential medical research but would also enhance their reputation and market presence by participating in high-stake government-funded projects like this one. The unique demands of this project highlight the need for specialised skills and capabilities, ensuring that only well-suited firms like Simbec-Orion, with comprehensive service offerings, can compete effectively.

Find more tenders on our Open Data Platform.
How relevant is this notice?

D3 Tenders Premium

Win More Public Sector Contracts

AI-powered tender discovery, pipeline management, and market intelligence — everything you need to grow your public sector business.

Notice Title

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

Notice Description

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.

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-04d494
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/001841-2025
Current Stage
Award
All Stages
Award

Procurement Classification

Notice Type
Award Notice
Procurement Type
Standard
Procurement Category
Goods
Procurement Method
Limited
Procurement Method Details
Negotiated without publication of a contract notice
Tender Suitability
Not specified
Awardee Scale
SME

Common Procurement Vocabulary (CPV)

CPV Divisions

33 - Medical equipments, pharmaceuticals and personal care products


CPV Codes

33000000 - Medical equipments, pharmaceuticals and personal care products

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
£116,645 £100K-£500K

Notice Dates

Publication Date
20 Jan 20251 years ago
Submission Deadline
Not specified
Future Notice Date
Not specified
Award Date
1 Jan 20251 years ago
Contract Period
Not specified - Not specified
Recurrence
Not specified

Notice Status

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

Contracting Authority (Buyer)

Main Buyer
NHS WALES SHARED SERVICES PARTNERSHIP (NWSSP) - PROCUREMENT SERVICES
Contact Name
Nia Price
Contact Email
nia.price@wales.nhs.uk
Contact Phone
+44 2921501500

Buyer Location

Locality
CARDIFF
Postcode
CF14 4HH
Post Town
Cardiff
Country
Wales

Major Region (ITL 1)
TLL Wales
Basic Region (ITL 2)
TLL5 South East Wales
Small Region (ITL 3)
TLL52 Cardiff and Vale of Glamorgan
Delivery Location
TLL22 Cardiff and Vale of Glamorgan

Local Authority
Cardiff
Electoral Ward
Heath
Westminster Constituency
Cardiff North

Supplier Information

Number of Suppliers
1
Supplier Name

SIMBEC RESEARCH

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

Download

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.

{
    "tag": [
        "compiled"
    ],
    "id": "ocds-h6vhtk-04d494-2025-01-20T12:02:11Z",
    "date": "2025-01-20T12:02:11Z",
    "ocid": "ocds-h6vhtk-04d494",
    "description": "NHS Wales Shared Services Partnership are publishing this notice on behalf of; Cardiff and Vale University Health Board Woodland House Maes-y-Coed Road Cardiff CF14 4HH A standstill period of 10 calendar days from publication of this notice will be observed by the authority prior to entering into a contract. NOTE: To register your interest in this notice and obtain any additional information please visit the Sell2Wales Web Site at https://www.sell2wales.gov.wales/Search/Search_Switch.aspx?ID=147495. (WA Ref:147495)",
    "initiationType": "tender",
    "tender": {
        "id": "ocds-h6vhtk-04d494",
        "legalBasis": {
            "id": "32014L0024",
            "scheme": "CELEX"
        },
        "title": "Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: \"Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision\"",
        "status": "complete",
        "classification": {
            "scheme": "CPV",
            "id": "33000000",
            "description": "Medical equipments, pharmaceuticals and personal care products"
        },
        "mainProcurementCategory": "goods",
        "description": "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.",
        "lots": [
            {
                "id": "1",
                "description": "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.",
                "hasOptions": false
            }
        ],
        "items": [
            {
                "id": "1",
                "additionalClassifications": [
                    {
                        "scheme": "CPV",
                        "id": "33000000",
                        "description": "Medical equipments, pharmaceuticals and personal care products"
                    }
                ],
                "deliveryAddresses": [
                    {
                        "region": "UKL22"
                    }
                ],
                "relatedLot": "1"
            }
        ],
        "procurementMethod": "limited",
        "procurementMethodDetails": "Negotiated without publication of a contract notice",
        "coveredBy": [
            "GPA"
        ],
        "procurementMethodRationaleClassifications": [
            {
                "scheme": "TED_PT_AWARD_CONTRACT_WITHOUT_CALL",
                "id": "D_MANUF_FOR_RESEARCH",
                "description": "The products involved are manufactured purely for the purpose of research, experiment, study or development under the conditions stated in the directive"
            }
        ],
        "procurementMethodRationale": "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."
    },
    "awards": [
        {
            "id": "001841-2025-CAV-VEA (24-25) 169-1",
            "relatedLots": [
                "1"
            ],
            "status": "active",
            "suppliers": [
                {
                    "id": "GB-FTS-135479",
                    "name": "SIMBEC RESEARCH LIMITED"
                }
            ]
        }
    ],
    "parties": [
        {
            "id": "GB-FTS-135478",
            "name": "NHS Wales Shared Services Partnership (NWSSP) - Procurement Services",
            "identifier": {
                "legalName": "NHS Wales Shared Services Partnership (NWSSP) - Procurement Services"
            },
            "address": {
                "streetAddress": "Woodland House, 2nd Floor, Maes-Y-Coed Road",
                "locality": "Cardiff",
                "region": "UK",
                "postalCode": "CF14 4HH",
                "countryName": "United Kingdom"
            },
            "contactPoint": {
                "name": "Nia Price",
                "telephone": "+44 2921501500",
                "email": "nia.price@wales.nhs.uk"
            },
            "roles": [
                "buyer"
            ],
            "details": {
                "url": "http://nwssp.nhs.wales/ourservices/procurement-services/",
                "buyerProfile": "https://www.sell2wales.gov.wales/search/Search_AuthProfile.aspx?ID=AA0221",
                "classifications": [
                    {
                        "scheme": "TED_CA_TYPE",
                        "id": "BODY_PUBLIC",
                        "description": "Body governed by public law"
                    },
                    {
                        "scheme": "COFOG",
                        "id": "07",
                        "description": "Health"
                    }
                ]
            }
        },
        {
            "id": "GB-FTS-135479",
            "name": "SIMBEC RESEARCH LIMITED",
            "identifier": {
                "legalName": "SIMBEC RESEARCH LIMITED"
            },
            "address": {
                "streetAddress": "Simbec House Merthyr Tydfil Industrial Park, Pentrebach",
                "locality": "Merthyr Tydfil",
                "region": "UKL",
                "postalCode": "CF484DR",
                "countryName": "United Kingdom"
            },
            "contactPoint": {
                "telephone": "+44 1753944092"
            },
            "roles": [
                "supplier"
            ],
            "details": {
                "scale": "sme"
            }
        },
        {
            "id": "GB-FTS-111",
            "name": "High Court",
            "identifier": {
                "legalName": "High Court"
            },
            "address": {
                "streetAddress": "Royal Courts of Justice, The Strand",
                "locality": "London",
                "postalCode": "WC2A 2LL",
                "countryName": "United Kingdom"
            },
            "contactPoint": {
                "telephone": "+44 2079477501"
            },
            "roles": [
                "reviewBody"
            ]
        }
    ],
    "buyer": {
        "id": "GB-FTS-135478",
        "name": "NHS Wales Shared Services Partnership (NWSSP) - Procurement Services"
    },
    "contracts": [
        {
            "id": "001841-2025-CAV-VEA (24-25) 169-1",
            "awardID": "001841-2025-CAV-VEA (24-25) 169-1",
            "status": "active",
            "value": {
                "amount": 116645,
                "currency": "GBP"
            },
            "dateSigned": "2025-01-01T00:00:00Z"
        }
    ],
    "language": "en"
}