In Vivo Small Animal Models

We recognize that standard study designs or animal models might not fit your novel technology, address your unique endpoints, or provide data to support additional marketing claims. Our technical experts will work with you to customize a study design or select an animal model that meets your specific needs, while maintaining the required level of regulatory compliance. In addition, when consulting on a test strategy, our regulatory experts may recommend or address a regulatory agency inquiry through an in vivo study using a small animal model that adequately addresses product safety or efficacy, leveraging industry standards as well as horizontal guidance documents. We work with you to quickly adapt to your needs, offering flexibility in our studies to make changes that best suit the goals and outcomes of the study in support of your product or device.

Preclinical Animal Model Development

Preclinical In Vivo Surgical / Injection Studies

Route(s): ID, IM, IP, IV, PO, SC

Infection Models

Antimicrobial Assessment

Resorption

Tissue Defect, Repair, Regeneration

• Dermal, muscular (e.g. hernia), osseous (e.g. tibia), soft tissue (e.g. Achilles tendon, dura)

Toxicity

• Subchronic, Chronic

Biodistribution

Tumorgenicity

Wound Healing

Pharmacokinetics

Drug Elution / Analytical Chemistry
 

• Systemic and local endpoints combination study

On-Site Services

Board Certified

• Toxicologists
• Veterinary PathologistsIn-house IACUC, AAALAC accreditation

BSL-1, ABSL-1, BSL-2, and ABSL-2

Cell production

Guideline Expertise and Consultation

GMP, GLP and non-GLP

ISO 10993

• Local Effects / Tissue Response
• Irritation/Sensitization
• Systemic Toxicity

Japanese MHLW