We are an Expert Preclinical CRO specializing in advancing Drug and Medical Device developments.
We are an Expert Preclinical CRO specializing in advancing Drug and Medical Device developments.
Drug Development
Our strong preclinical expertises in cell-free and cell-based analyses, ex vivo and in vivo analyses, murine animal models, and dissection and necropsy will simplify your program and help advance it more rapidly to clinical development.
Medical Device Development
From our long term experience with medical devices and combination products, we can help advance your device design through specifications, risk analysis, animal models, design verification and validation, manufacturing, human factors, and clinical allculminating into a Master Device File (MDF) for regulatory approval.
Regulatory Enabling Capabilities
With a combined experience of 40+ years enabling IND/IDE clinical trial approvals with the FDA, our team can help advance your drug or device into clinical development and and improve your success in meeting primary efficacy and safety endpoints.