Minkyung Shin, CEO of Selta Square
Founded to enhance the efficiency of pharmaceutical safety management and support global regulatory compliance
Completed approximately 9 billion won in Series A investment attraction, achieving commercialization with multiple domestic and international pharmaceutical companies within three years of being founded
“Selta Square is a company that predicts drug side effects based on lifecycle safety data and drives new insights through monitoring, evaluation, analysis, and management.”
Its flagship items include AI/DX-based pharmaceutical and medical device safety management, AI/big data-based predictions of personalized drug side effects, and an AI-based RWD data analysis platform that replaces post-marketing clinical trials.
Currently collaborating with over 60 pharmaceutical companies through signed contracts, the company is preparing for global expansion beyond the Korean market. As a convergence technology company where medical, statistical, AI, and regulatory experts integrate, it has aimed for global-level quality standards since its founding.
“Our flagship platform, iVigilance Square, is a SaaS platform specialized for pharmacovigilance. Another core service, RMP OneScope™, presents a measure to replace post-marketing studies and clinical trials through technology convergence, enabling big data analysis based on risk management—the core of post-marketing safety management systems.”
Selta Square’s competitive advantage lies in being the world’s only PV-specialized platform combining regulatory expertise with AI technology. It possesses data standardization technology compatible with global safety databases like Oracle Argus and has secured audit readiness reliability through quality systems (GVP, ICH E2B, CSV, ISO27001, etc.).
Another strength is its Safety Orchestration model, which encompasses both regulation and science, positioning it beyond a simple IT company. Its structure also facilitates easy connectivity with local regulatory institutions (EMA (European Medicines Agency), FDA) during global expansion. Its high technical barriers to entry at the intersection of AI and regulation also constitute a competitive advantage.
Key clients include pharmaceutical companies, biopharmaceutical companies, medical device manufacturers, and medical clinics and hospitals. Beyond direct sales, Selta Square prioritizes networking based on expertise and trust through presentations and case studies at conferences, academic meetings, and regulatory agency seminars.
It has delivered lectures and case studies at sessions hosted by the Drug Information Association (DIA), Korea National Enterprise for Clinical Trials (KoNECT), the Korea National Enterprise for Clinical Trials, and the KFDA, earning recognition for its expertise. It maintains global Tech Alliance partnerships through collaborations with Oracle and Microsoft. Additionally, it consistently publishes thought leadership content in various formats and is advancing its global expansion through collaboration with Gartner and the establishment of a go-to-market strategy.
Selta Square completed approximately 9 billion won in Series A investment attraction last December and plans a Series B investment in early 2027.
Led by top-tier experts in their respective fields, the company’s approximately 40-member team is organized into domain experts, IT development, QA, and business strategy. Furthermore, it has already established a systematic system capable of passing vendor evaluations by global pharmaceutical headquarters.
Regarding future plans, Shin stated, “We will drive market growth alongside iVigilance Square’s U.S. expansion and our RWD data-based risk management, prediction, and clinical trial replacement platform,” adding, “Ultimately, we aim to establish ourselves as the world’s first Global Safety Data Orchestrator.”
Founded: July 2021
Main business: platform for AI/DX-based pharmaceutical and medical device safety management, AI/big data-based personalized drug side effect prediction, and AI-based RWD data analysis for post-market clinical alternatives
Achievements: Achieved commercialization with multiple Korean and international pharmaceutical companies within three years of being founded; Led industry standardization through projects with KFDA and global pharmaceutical companies; Secured a foundation for global expansion through partnerships with big tech companies like IBM, Microsoft, Gartner, and Oracle; Filed numerous patents and papers; Commercialized the world’s first AI-based PV SaaS integrated safety management platform
reporter jinho lee
jinho2323@hankyung.com
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