MRC Sleep Study - Purchase of IMP

Tender description

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