• 임상 CRO
• SMO
• 임상 솔루션
• 컨설팅
• DCT
• 기타 - MFDS Regulatory Strategy & Approval Support

We are a specialized CRO focused on human clinical trials for health functional foods, providing end-to-end integrated services from study design through regulatory submission support. Our capabilities cover the full clinical trial lifecycle, including protocol development, site feasibility assessment and selection, clinical trial operations (vendor management, IRB submissions, and monitoring), data management, statistical analysis, and preparation of final study reports. In addition, we offer regulatory strategy and approval support aligned with MFDS requirements, leveraging clinical evidence to support approval pathways. Our services include gap analysis, preparation of submission documents, and scientific and regulatory responses to authority inquiries. By closely integrating clinical operations, biostatistics, and regulatory affairs, we deliver regulatory-ready clinical packages with strong data integrity and logical consistency, tailored to regulatory review expectations.