PURCON 2000 EASE: Drugs trial

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. Additional information: 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