SMPV Limited

SMPV Limited is a specialist consultancy supporting biopharmaceutical companies in strengthening their pharmacovigilance (PV) and quality systems. With over 20 years in the pharmaceutical industry, we bring practical insight and hands-on experience in drug safety, regulatory compliance, and quality management. We understand the challenges faced by growing pharmaceutical organisations with limited resources, evolving regulations, and the need to be inspection ready. That’s why we offer tailored, scalable solutions that embed quality principles into everyday PV operations, helping to improve systems, manage risks, and support better outcomes for patients. 🎯 Our Mission To support biopharma companies in building efficient, compliant pharmacovigilance systems through the application of quality and risk management. 🔍 What We Do * Design and optimisation of pharmacovigilance systems * Implementation of Quality Management Systems (QMS) for PV * SOP development and process harmonisation * Audit readiness and regulatory inspection support * Integration of risk management into daily PV activities * Training and coaching for PV and QA teams 🤝 Who We Support * Pharmaceutical and biotech companies * Organisations preparing for regulatory inspections or navigating changes 🌟 Why Choose SMPV Limited * Over 20 years of practical experience in PV and quality * Knowledge and understanding of global regulatory frameworks (MHRA, EMA, FDA, etc.) * Scalable, fit-for-purpose quality solutions tailored to your organisation * A focus on patient safety and operational improvement