Tender Summary

PURCON 2000 EASE: Drugs trial

Buying Organisation

University of East Anglia

Contract Value

Unknown

Tender 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.

Tender categories (products & services required)

Research and experimental development services (CPV 73100000)

Region

East (UKH)

Buyer Information