Speculative Notice – NATIONAL

1 Authority Details

1.1

Authority Name and Address

1.2

Address from which further information may be obtained

As in 1.1

2 Contract Details

2.1

Title

Medical Health Registry Authority Remedial Plan PETIC

2.2

Description of the goods or services required

The following specialist Medical Consultancy Services are being sought by CU/C&VUH for their PETIC Facility over the period July 2022 to February 2023:

1. A Gap Analysis of Cardiff University/Cardiff & Vale University Hospital (CU/C&VUH) PETIC’s Quality Management Systems by either Qualified Persons or ex MHRA inspectors to take place June - August 2022. The key output for this work will be a comprehensive Report and Action Plan for any corrective measures required.

2. To conduct a retrospective review of PETIC Non-conformance's to MHRA GMP standards from Feb 2021- Feb 2022 inclusive, by suitably qualified persons or ex MHRA inspectors. A comprehensive Report on any non-conformances plus an Action Plan for corrective actions will be the required output.

3. A third party inspection of the CU/C&VUH PETIC facility to MHRA GMP standards to take place December 2022 - Jan 2023. An inspection report that is viewed as authoritative and credible by the MHRA, will be the required output.

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=120442.

2.3

Notice Coding and Classification

3 Administrative Information

3.1

Reference number attributed to the notice by the contracting authority

3.2

Estimated Start of the Award Procedure

4 Other Information

4.1

Additional Information

(WA Ref:120442)

4.2

Download Additional Documentation

4.3

Publication date of this notice