Tender: MHRA Framework for Medicines Licensing Assessors — Pharmaceutical, Clinical and Non‑Clinical Assessments

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The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking suppliers to join a framework to provide medicines licensing assessor services, delivering assessments of complex pharmaceutical, clinical and non‑clinical regulatory data and evidenced judgements within the MHRA assessment and quality assurance framework. These assessments may relate to marketing authorisation applications, clinical trial applications and other compliance activities, with supplier resources deployed on a flexible basis to supplement MHRA capacity and capability. MHRA will appoint up to four suppliers to each of three Lots: Lot 1 — Pharmaceutical Assessment (assessment of pharmaceutical/quality data in compliance with Module 3 and Module 2 quality sections of the Common Technical Document); Lot 2 — Medical Assessment (assessment of clinical, statistical and clinical pharmacology data in compliance with Module 5 and Module 2 clinical sections of the Common Technical Document); and Lot 3 — Non‑Clinical Assessment (assessment of non‑clinical data in compliance with Module 4 of the Common Technical Document).