Your Preclinical Research Partner
From early feasibility through GLP validation, we help medical device teams generate the evidence regulators expect, across cardiovascular, neurologic, and the full range of therapeutic applications.
Preclinical Expertise
Full Service Preclinical Support
From study planning through regulatory submission, we provide the infrastructure and expertise your medical device needs. GLP compliant studies, ISO 10993 biocompatibility, pathology services, and FDA submission support all under one roof.
GLP & Non-GLP Study Design
Biocompatibility Evaluation (ISO 10993)
Board Certified Pathology Services
Regulatory Strategy & FDA Submission Support
Areas of Expertise
Four decades of specialized expertise across cardiovascular, neurological, gastrointestinal, and additional therapeutic categories.
Cardiovascular
Transcatheter valves, LVADs, and drug-eluting stents proven across the extreme conditions they face clinically.
Neurologic
Shunts, dural sealants, and spinal nerve stimulation, where failure modes have zero tolerance.
Gastrointestinal
Bariatric devices, surgical robotics, and tissue sealants under intestinal pressure.
Urogenital
Organ preservation and stone fragmentation, validated to GLP protocols FDA reviewers recognize.
Musculoskeletal
Joint repair, critical size bone defects, and fracture repair through the healing process.
Respiratory
Lung volume reduction and sealants tested against cycling respiratory pressure.
Dermatologic
Wound healing and injectable fillers measured for closure, volume, and migration.
State of the art Lab Environments
Our 20,000 sq. ft. facility is designed to replicate clinical environments, ensuring your device is tested under the most realistic conditions possible.
Tour Our FacilityDual Cath Labs with Philips Azurion Systems
Dedicated Surgical Operating Suites
Advanced Imaging (CT, Fluoroscopy, ICE)
AAALAC Accredited & GLP Compliant
Ready to Start Your Study?
Partner with a team that treats your innovation with the precision it deserves.
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