MRC Sleep Study - Understanding the link between sleep and Alzheimers

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