Regulatory Affairs support division
We offer life-cycle support for integration tied to key infrastructure, alongside regulatory consulting for the development of sophisticated medical products.
Objective
- Facilitate the development of advanced medical products at a global standard through lifecycle support.
- Provide strategic decision-making support at each phase of development to accelerate the path to commercialization.
Key Features
- Implement an integrated development support program that connects foundational technology infrastructure with regulatory consulting from the strategy formulation phase through to commercialization.
- Deliver regulatory insights for biopharmaceuticals and advanced medical devices.
Eligibility
- Biopharmaceuticals (antibody drugs, protein drugs, biosimilars, etc.)
- Advanced biopharmaceuticals (cell therapies, gene therapies, integrated medical products, etc.)
- Medical devices (high-risk human implantable medical devices, optical integrated medical devices, in vitro diagnostic devices, etc.)
Application for Support
- Emailconsulting@kbiohealth.kr
- Senior ResearcherYoon Sae-bom
- Phone+82-43-200-9176