RegTrac

About RegTrac

RegTrac helps healthcare and consumer-product companies navigate complex regulatory requirements, build effective quality systems and bring compliant products to international markets. We support manufacturers, developers, importers and distributors across Medical Devices, IVDs, Software as a Medical Device (SaMD), Cosmetics and Consumer Products. Our services include: • Regulatory strategy, classification and market-entry planning • Product registrations and regulatory submissions • Quality Management Systems (QMS) • Technical documentation and gap assessments • Clinical and performance evidence support • Post-market surveillance and ongoing compliance • UKRP, EU AR, CH-REP and US Agent services Why work with RegTrac? 🌍 Global market support Through RegTrac entities and established partners, we support businesses across the UK, European Union, Switzerland, the United States, India, the Middle East and other international markets. 📋 Product-lifecycle expertise From early regulatory planning and registration through market launch, post-market activities and regulatory change management. 🎯 Right-first-time focus We identify regulatory gaps early, strengthen documentation and help reduce avoidable delays, rework and compliance risk. 🤝 Flexible regulatory partnership We work as an extension of your team, providing focused project support or ongoing regulatory and quality oversight. 🎓 Regulatory training Our industry-led programmes help professionals and organisations strengthen practical regulatory knowledge and respond to evolving requirements. Whether you’re developing a new product, entering another market, strengthening your QMS or looking for an established local representative, RegTrac can help. 📩 info@reg-trac.com 🌐 www.reg-trac.com