SagaReg

SagaReg is a pioneering AI-driven regulatory technology company based in Reykjavík, 59, transforming how pharmaceutical and biotechnology companies manage their regulatory submissions and compliance processes. Founded with the vision to simplify the highly complex and data-intensive world of global drug approvals, SagaReg provides a unified digital platform that automates dossier preparation, document management, and submission workflows for regulatory affairs teams across the life sciences industry. At the heart of SagaReg’s platform lies a powerful AI and automation engine that intelligently compiles data from diverse research and clinical sources, structures regulatory documents, and ensures adherence to international compliance standards such as EMA, FDA, and ICH. This automation significantly reduces manual workload, shortens submission timelines, and minimizes the risk of human error — empowering regulatory professionals to focus on strategy, innovation, and faster market access. SagaReg’s platform enables seamless collaboration between pharmaceutical companies, CROs, and regulatory bodies, ensuring transparent, traceable, and audit-ready communication throughout the drug approval lifecycle. The system’s modular design allows clients to adapt it to their specific therapeutic areas, regulatory frameworks, and organizational needs, making it a scalable solution for both emerging biotech startups and global pharmaceutical enterprises. The company’s innovation has earned recognition in the Nordic life sciences ecosystem, including the prestigious Gullegg 2025 Innovation Award, acknowledging SagaReg’s contribution to advancing regulatory intelligence and automation. Through its continuous R&D efforts, SagaReg aims to build a future where AI-powered regulatory systems drive faster access to safe and effective medicines worldwide. With its commitment to accuracy, agility, and compliance, SagaReg stands at the intersection of artificial intelligence and pharmaceutical regulation — empowering life science organizations to navigate complex submission environments with confidence, precision, and speed.