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CRDMO Service

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