Source: https://tendernation.io/opportunities/01a13cb8-7c7c-70d4-9426-5af88723812c/purcon-2000-ease-drugs-trial

closed GB open procedure

# PURCON 2000 EASE: Drugs trial

[University of East Anglia](https://tendernation.io/buyers/university-of-east-anglia)

Estimated value

Not stated

Published

25 Apr 2023

Deadline

Closed

23 May 2023

## Who can bid

- Open procedure

    Anyone can submit a full tender; there is no shortlisting stage.

## About this tender

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.

Additional information: If you're interested in this contract, documents are available on UEA's In-Tend

([in-tendhost.co.uk](https://In-Tendhost.co.uk/universityofeastanglia/aspx/Home))

Is a Recurrent Procurement Type? : No

## CPV classification

Research and experimental development services

Source

Contracts Finder (UK)

[View official notice](https://www.contractsfinder.service.gov.uk/notice/5894df7b-15a0-4824-9568-3a3a8a268e2d)

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