Preclinical Excellence for Safer, Smarter Medical Innovations
At HT Biosciences, we specialize in GLP-compliant in vivo testing for medical devices, delivering robust preclinical data to accelerate regulatory approvals (FDA, CE, NMPA) and ensure patient safety. Our advanced animal models, state-of-the-art facilities, and ISO 10993-aligned protocols empower innovators to validate device performance, biocompatibility, and long-term efficacy with confidence.
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.