Published date: 25 April 2023

Last edited date: 26 April 2023

Closed opportunity - This means that the contract is currently closed. The buying department may be considering suppliers that have already applied, or no suitable offers were made.


Closing: 23 May 2023, 11:59am

Contract summary

Industry

  • Research and experimental development services - 73100000

Location of contract

NR4 7TJ

Value of contract

£0

Procurement reference

IT-37-825-PURCON 2000

Published date

25 April 2023

Closing date

23 May 2023

Closing time

11:59am

Contract start date

2 June 2023

Contract end date

28 February 2027

Contract type

Supply contract

Procedure type

Other

Contract is suitable for SMEs?

No

Contract is suitable for VCSEs?

No

Description

In summary, we are seeking an MIA (IMP) Licenced manufacturer who can:

o Provide support for regulatory (MHRA) application. For example, provide the IMPD within 1 month from contract being fully executed (contract to start on 01/06/2023 at the earliest) and support the creation of the annex 13 compliant labels.
o Source Sertraline 25 mg film-coated tablets (crushable and with consideration of size and shape for suitability for patients with dysphagia).
o Undertake manufacturing activities as needed for the active (e.g. de-blistering)
o Undertake matched placebo manufacture (film coated tablets)
o Primary packaging and labelling (MHRA approved; group A and B blinding) of active and placebo into bottles (including supply of the bottles)
o QA and QC Testing (including stability study for active and placebo)
o QP Services (e.g. batch review and release)
o Store and distribute (both in temperature controlled and monitored environments) the trial drugs to 25 UK sites (estimated 40 shipments)
o Have the IMP ready to be shipped to sites by January 2024.

Full details will be contained within the RFQ document.

More information

Links

Additional text

If you're interested in this contract, documents are available on UEA's In-Tend
(https://In-Tendhost.co.uk/universityofeastanglia/aspx/Home)

Is a Recurrent Procurement Type? : No

About the buyer

Contact name

Denislava Ivanova

Address

University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom

Telephone

00000 000000

Email

denislava.ivanova@uea.ac.uk