Section one: Contracting authority/entity
one.1) Name and addresses
NHS Wales Shared Services Partnership (NWSSP) - Procurement Services
Woodland House, 2nd Floor, Maes-Y-Coed Road
Cardiff
CF14 4HH
Contact
Nia Price
Telephone
+44 2921501500
Country
United Kingdom
NUTS code
UK - United Kingdom
Internet address(es)
Main address
http://nwssp.nhs.wales/ourservices/procurement-services/
Buyer's address
https://www.sell2wales.gov.wales/search/Search_AuthProfile.aspx?ID=AA0221
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Supply and Manufacture of Investigational Medicinal Products (IMPs) for the Clinical Trial: "Examining Antibiotics for Ulcerated Skin Cancer Surgical Excision"
two.1.2) Main CPV code
- 33000000 - Medical equipments, pharmaceuticals and personal care products
two.1.3) Type of contract
Supplies
two.1.4) Short 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £116,645
two.2) Description
two.2.2) Additional CPV code(s)
- 33000000 - Medical equipments, pharmaceuticals and personal care products
two.2.3) Place of performance
NUTS codes
- UKL22 - Cardiff and Vale of Glamorgan
two.2.4) Description of the procurement
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.
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Negotiated without a prior call for competition
- The products involved are manufactured purely for the purpose of research, experiment, study or development
Explanation:
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.
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section five. Award of contract/concession
Contract No
CAV-VEA (24-25) 169
A contract/lot is awarded: Yes
five.2) Award of contract/concession
five.2.1) Date of conclusion of the contract
1 January 2025
five.2.2) Information about tenders
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor/concessionaire
SIMBEC RESEARCH LIMITED
Simbec House Merthyr Tydfil Industrial Park, Pentrebach
Merthyr Tydfil
CF484DR
Telephone
+44 1753944092
Country
United Kingdom
NUTS code
- UKL - Wales
The contractor/concessionaire is an SME
Yes
five.2.4) Information on value of contract/lot/concession (excluding VAT)
Total value of the contract/lot/concession: £116,645
Section six. Complementary information
six.3) Additional information
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)
six.4) Procedures for review
six.4.1) Review body
High Court
Royal Courts of Justice, The Strand
London
WC2A 2LL
Telephone
+44 2079477501
Country
United Kingdom