Medicines and Healthcare Products Regulatory Assessment Services Framework

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking to establish a framework of specialist suppliers to provide medicines regulatory assessment services. MHRA regulates medicines, medical devices, and blood components for transfusion in the UK, and carries out safety, quality, and efficacy assessments of new products, clinical trials, manufacturing inspections, and ongoing product safety monitoring. This opportunity allows MHRA to expand its in-house expertise through flexible deployment of external specialists to meet growing demand in the UK life sciences sector. Suppliers will assess complex clinical and non-clinical regulatory data and provide evidence-based judgements within MHRA's assessment and quality assurance framework, supporting marketing authorisation applications, clinical trial applications, and compliance activities. The framework comprises three specialised lots: - Lot 1: Pharmaceutical Assessment (quality and pharmaceutical data) - Lot 2: Medical Assessment (clinical, statistical, and clinical pharmacology data) - Lot 3: Non-Clinical Assessment (non-clinical safety and efficacy data) Up to four suppliers meeting minimum criteria may be awarded a place on each lot. Deployment is flexible, enabling MHRA to scale capacity as needed to support increased growth in life sciences while maintaining patient safety standards.