Comment from TriApex Laboratories Co., Ltd. (TriApex)

Summary: TriApex Laboratories Co., Ltd., a contract research organization (CRO), supports the draft guidance but suggests improvements regarding third-party AI validation and non-clinical AI adoption. They propose a "Partial Disclosure + Third-Party Certification" model for proprietary "black-box" AI tools and suggest creating a "Preclinical AI Consultation" process to provide clearer pathways for non-clinical applications.