Preclinical CRO Services

GLP Large Animal Studies

AAALAC-accredited facilities | ISO 10993-compliant | FDA, EMA and NMPA-aligned protocols

HuaTeng Biotechnology provides GLP-compliant large animal models to support comprehensive medical device validation. Our studies generate scientifically rigorous preclinical data, helping to de-risk regulatory pathways and accelerate global approvals. We bring deep expertise across orthopaedic, cardiovascular, dental, and active implant studies, with strong emphasis on species-specific physiological relevance and translational study design.

Preclinical Large Animal Studies for Medical Devices

GLP-Compliant | Translationally Relevant | Globally Aligned

Our AAALAC-accredited facilities conduct studies in accordance with ISO 10993 (biocompatibility) and regulatory expectations across FDA, EMA and NMPA. We help bridge critical translational gaps by delivering robust, decision-ready preclinical data.

We achieve this through:
· Anatomically predictive models, including ovine and caprine orthopaedic models and porcine cardiovascular systems
· Surgical excellence under full IACUC oversight
·Clinically relevant endpoints, including histomorphometry, μCT and biomechanical testing

Core Service Areas

Orthopaedic Implant Testing

Models

Ovine, caprine, porcine and canine

Assessments

Osseointegration and bone–implant interface analysis (μCT, histomorphometry)
Wear debris and biocompatibility (ISO 10993-6, -10)
Dynamic loading simulations (ASTM F2996)
Applications in spinal devices, joint replacements and trauma fixation

Cardiovascular Device Evaluation

Models

Porcine and ovine

Applications

Endovascular devices, including stents, TAVR and occlusion systems
Thrombogenicity assessment (ISO 10993-4) and haemodynamic evaluation
Chronic implantation studies (up to 180 days)
Advanced imaging endpoints, including angiography, IVUS and OCT

Dental Implant & Maxillofacial Studies

Models

Minipig, canine and non-human primate

Study Focus

Soft and hard tissue integration (ISO 22911)
Alveolar bone healing kinetics
Guided bone regeneration (GBR) material performance

Active Implantable Devices

Device Scope

Pacemakers, neurostimulators and drug delivery systems

Evaluation & Testing

Electromagnetic compatibility (EMC) (IEC 60601)
Battery longevity and in vivo performance
Histopathological response to implanted electronics

Compliance & Quality

Accreditations: AAALAC International | GLP (OECD)

Regulatory Support: Audit-ready reports for FDA 510(k), PMA, CE Mark and NMPA submissions

Biocompatibility Integration: Endotoxins, cytotoxicity and sensitisation testing (ISO 10993 series)

Technical Capabilities

Integrated Platforms for High-Quality Preclinical Data

Area Technologies & Capabilities
Imaging μCT, angiography, MRI and radiography
Histology Undecalcified sectioning, SEM and immunohistochemistry (IHC)
Biomechanics Instron mechanical testing and finite element analysis (FEA)
Data Analytics GLP-compliant electronic lab notebooks (ELN) and statistical power analysis

Vascular Medical Devices

Learn More

Preclinical Evaluation Services for Structural Heart Devices

Learn More

Preclinical Evaluation Services for Orthopedic Materials

Learn More

Preclinical Evaluation Services for Dental Materials

Learn More

Preclinical Evaluation Services for Dermal Repair Devices

Learn More

Preclinical Evaluation Services for Hemostatic Devices

Learn More

Why Choose Huateng Bio for GLP-Compliant Testing?

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.

Send Us a Message

By using this form, you consent to HuaTeng Biotechnology storing and processing your personal data according to our [Privacy Policy] . We only use this information to resolve your inquiry.

Custom Hotline

+86 15217198166


Email

ht@htscience.com

Our WeChat

Our WeChat

Our WeChat

Scan to chat with us on WeChat!

Contact Us
Online Service
Hello! May I help you with something?