AAALAC-accredited facilities | ISO 10993, FDA/EMA/NMPA aligned protocols | Species-specific physiologic relevance
HuaTeng Biotechnology delivers GLP-Compliant Large Animal Models for Comprehensive Medical Device Validation, providing scientifically rigorous preclinical data to de-risk regulatory pathways. As a trusted preclinical CRO, we specialize in orthopedic, cardiovascular, dental & active implant studies with species-specific physiologic relevance.
Global Compliance: AAALAC-accredited facilities with IACUC protocols aligned with EU Directive 2010/63/EU and USDA standards.
Advanced Imaging: DSA, IVUS, angiography, and micro-CT for real-time device performance tracking.
Custom Model Development: Species-specific animal models for complex disease states.
Histopathology Suite: SEM/TEM analysis with GLP-grade reporting for PMDA/CE Mark submissions.