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Qualified Person Service for Investigational Medicinal Products (IMP)

NHS Blood and Transplant

Planned

Key facts

Closing date
Not stated by the buyer
Buyer's estimated value
£216,000 (excl. VAT) The buyer's own estimate, not income to you.
Contract period
30 Mar 2027 to 31 Mar 2030
Procedure
Not stated
Notice type
Preliminary market engagement notice (UK2)
Suitable for SMEs (per buyer)
Yes

Decision brief

Taken from the buyer's published notice (shown as written, shortened where long). Tenderpatch has not added to or interpreted it. Always read the official documents before bidding.

How bids will be scored
Not stated in the notice.
Conditions of participation (what you must show)
None published in the notice. They may be in the tender documents.
Contract length and extensions
30 Mar 2027 to 31 Mar 2030.
How to submit
Not stated in the notice.
Tender documents
No document links in the notice. Use the official notice link.
New to public tenders? Plain-English guide to this page
Framework
An agreement that sets terms for work the buyer may order later, often from several suppliers. The value shown usually covers the whole agreement, not one job.
Open for bids / closing date
You must submit by the closing date and time, normally through the buyer's own online portal. Late bids are normally refused.
Clarification questions
A deadline for asking the buyer questions about the tender. It is earlier than the closing date.
Conditions of participation
What the buyer asks suppliers to show before they can be considered, such as experience, insurance or accreditations.
Bids are scored on
How the buyer will compare bids, usually a split between price and quality. A 60/40 split in favour of quality means the cheapest bid will not necessarily win.
Lots
A tender can be split into parts. You can often bid for only the lots that suit you.
Area (ITL)
The buyer names an official statistical area for where the work is, not a street address. Check the tender documents for the actual sites.
UK4 and other notice codes
Official codes for the type of notice. A "tender notice" means bids are being invited.

General explanations written by Tenderpatch, not part of this notice.

Description

NHS Blood and Transplant is seeking to appoint a suitably qualified and experienced supplier to provide Qualified Person services in support of its portfolio of Investigational Medicinal Product manufacturing projects. The proposed service may include: reviewing and providing regulatory and quality input into selected regulatory submissions; advising on applicable regulatory, Good Manufacturing Practice and quality-compliance requirements for biological and Advanced Therapy Medicinal Product manufacturing projects; providing regulatory, GMP and quality input into the design and development of selected manufacturing processes and facilities; reviewing assigned batches and, where all applicable legal, regulatory, GMP, Clinical Trial Authorisation, Product Specification File and NHSBT quality-system requirements have been met, certifying batches for use in approved clinical trials; mentoring selected NHSBT staff undertaking the process of obtaining Qualified Person registration; and providing associated professional, regulatory and quality advice as required. Each Qualified Person proposed by the supplier will be expected to hold and maintain the qualifications, professional eligibility and regulatory status required to act as a Qualified Person for Investigational Medicinal Products in the UK. Proposed personnel should have recent and demonstrable experience of acting as a named Qualified Person on a UK Manufacturing and Import Authorisation for Investigational Medicinal Products, MIA(IMP), and of certifying IMP batches. Experience relating to biological, biotechnology, cell therapy and gene therapy medicinal products may also be required. The current anticipated level of support is approximately 24 to 48 days per year, with at least 50% of the support delivered on NHSBT premises and the remaining support delivered remotely, subject to agreement. The scope and requirements described in this notice are indicative and may be refined following preliminary market engagement.