
Business Area
01 Regulatory Affairs
시험계획서 개발 및 식약처 미팅을 비롯하여 IND부터 NDA(품목허가)까지 전반적인 과정에 최고의 전문인력으로 시간 및 비용을 절감 할 수 있는 차별화된 최상의 서비스를 제공합니다.
From all stages such as trial plan development, MFDS meeting and to IND and NDA(Item authorization), we provide a highly differentiated service that can cut time and cost with the best experts.

▶ Strategic Review & Planning
▶ Pre-IND meeting
▶ IND Dossier Preparation, Submission & Follow up
▶ IRB/IDE Dossier Preparation, Submission & Follow up
▶ Business Development & Project Management
▶ NDA Dossier Preparation, Submission & Follow up
▶ Licensing & Marketing support