PURCON 2000 EASE: Drugs trial
This is a contract result notice, not an open opportunity. Details from the official award data.
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.
What the supplier must deliver
O Provide support for regulatory (MHRA) application
o Provide support for regulatory (MHRA) application.
For example, provide the IMPD within 1
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 Primary packaging and labelling (MHRA approved
o Primary packaging and labelling (MHRA approved; group A and B blinding) of active and placebo into bottles (including supply of the bottles).
Derived from the notice text — always confirm against the original documents.
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- OCID
- a09ee691-4c68-4cc8-857e-da97c2458786
- Stage
- contract · Contract
- Source
- Contracts Finder
- Buyer ref
- IT-37-825-PURCON 2000
Contains public sector information licensed under the Open Government Licence v3.0. Source data © Crown copyright.
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