Tender: MRC Sleep Study – Purchase, Over‑encapsulation and Supply of IMP (Trazodone 100mg & Zolpidem 5mg)
Released 9 months ago
About
MRC is seeking a supplier for the purchase, manufacture and supply of investigational medicinal products (IMP) for an MRC Sleep Study, including support with regulatory approvals (preparation of an IMPD); sourcing Trazodone 100mg tablets and Zolpidem 5mg tablets; over-encapsulation of active products and manufacture of matched placebo capsules; packaging into bottles and provision of blinded labels in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 Amendment; holding appropriate MIA(IMP) authorisation and providing QP certification for use in the UK; storage and distribution to a UK pharmacy; ensuring full traceability of materials and processes including batch release certificates and audit trails; and conducting all work as instructed in accordance with relevant protocol, policy and work-instruction for the duration of the contract, with compliance to the 2004 Regulations and the 2025 Amendment when applied in April 2026 plus any other applicable regulatory requirements.
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