Provision of Quality Delivery Partner Services

On behalf of the Ministry of Defence (MOD), the National Armaments Director Group (NADG) (previously known as Defence Equipment and Support (DE&S)) would like to formally engage with industry via this UK4 Notice, through the Defence Sourcing Portal (DSP) which can be found here: https://contracts.mod.uk/go/56376600019F17DB668E The Chemical Biological Radiological Nuclear Team (CBRN) have a requirement to provide assurance and set standards to ensure that the Medical Countermeasures (MedCM) that are stored/supplied to the Front Line Command are maintained/ tested on a regular basis. To achieve this, Med CM needs to maintain the following external support: Failure to maintain this support will make CBRN non-compliant and acting illegally in respect of the work it is undertaking in respect of Medical Countermeasures.

An independent Qualified Person (QP) to ensure activities carried out by the Authority are in compliance with Good Manufacturing Practice. An independent Qualified Person for Pharmacovigilance (QPPV) and nominated deputy, to provide on-going support as required for the provision of a fully compliant Pharmacovigilance service.

A Regulatory Affairs Consultant, providing advice and services in order to ensure that the Authority is compliant with EU and UK Legislation. An Option for an independent Responsible Person (RP) to ensure activities are carried out in compliance with Good Distribution Practice (GDP).

Noting, this Option will only be taken up should CBRN be without either the substantive RPs, currently one in each of the Commissioning and Management Organisation and CBRN Delivery Team. In addition, there are multiple specialist disciplines that are to provide ad-hoc support to maintain our compliance to legal requirements and ensure our products meet the standards required by Defence and the pharmaceutical sector.

These specialist disciplines are also required to assist the Medical Countermeasures Advanced Development Programme (ADP), to achieve the appropriate licences where applicable. Regulatory engagement at an early stage to assist with this transition will ensure the products are ready and compliant with legislation enabling full licensure to be achieved quicker.

To support the above the following services and ad-hoc taskings are required: Qualified Person. Qualified Person for Pharmacovigilance.

Responsible Person. Regulatory Affairs Consultant.

Resilience Warehouse facilities. Adverse Events investigation.

Drug License Upkeep and Maintenance. Stability Testing of in-service inventory.

Publications (regulatory and technical). MHRA audits.

Batch Specific Variations. Transport and Disposal.

Continuing Professional Development. Due to security considerations, participation is limited to organisations with a registered UK legal entity.

The Cyber Risk Profile for this procurement identified by the Cyber Risk Assessment is Foundation Level 1. Total value (estimated) £*** excluding VAT (£5,876,000.00) £*** including VAT (£7,345,000.00) Above the relevant threshold Contract dates (estimated) 01 June 2027 to 31 May 2032 (5 years) Options Possible extension via options to 31 May 2037 (5 x 1 year periods) Any resulting Contract may include the following Contract Options to provide In Service Support for additional In Service Support Additional services The Authority reserve the right, at its absolute discretion, to not take up any or all the option(s) listed. Further information on the option(s) will be provided in the Tender.