MRC Sleep Study Clinical Trial Medication Procurement and Packaging Services
MRC Sleep Study - Purchase of IMP to include the following activities: - Support with regulatory approvals (preparation of IMPD) - Sourcing of Trazodone 100mg tablets & Zolpidem 5mg tablets - Over-encapsulation of active products & Manufacture of matched placebo capsules) - Packaging of products in to bottles, designin…
Source ID: UK-ocds-b5fd17-382ed01d-c684-44de-8801-60dbb1cd9b28
Estimated value
As published by the source; may be updated by the buyer.
Scope overview
MRC Sleep Study - Purchase of IMP to include the following activities: - Support with regulatory approvals (preparation of IMPD) - Sourcing of Trazodone 100mg tablets & Zolpidem 5mg tablets - Over-encapsulation of active products & Manufacture of matched placebo capsules) - Packaging of products in to bottles, designing and providing blinded labels in accordance with Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 Amendment to Regulations - Hold appropriate MIA(IMP) authorisation - QP Certification for use in the UK - Storage & Distribution to UK Pharmacy - Ensure full traceability of materials and processes, including batch release certificates and audit trails - Conducting such work as instructed, and in accordance with any relevant protocol / policy / work-instruction, for the duration of the contract.
- Compliance with Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 Amendment to Regulations when they are applied in April 2026 plus any other applicable regulatory requirements
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