The most-frequently turned to non-rodent species for regulatory submissions, the canine model is a critical component of nearly every successful IND application. BioLegacy’s standing canine colony and deep toxicology experience make us a well-suited partner for GLP-compliant canine studies designed to meet the most stringent global regulatory requirements. Our deep expertise in this well-characterized model, from pivotal repeat-dose toxicology to gold-standard cardiovascular safety pharmacology, provides unequivocal safety and PK/TK data required to establish safety margins, confidently select first-in-human doses, and de-risk your program’s transition to the clinic.
- IND-Enabling Studies: GLP-compliant toxicology and safety studies required for your regulatory submission.
- ICH-Compliant Safety Pharmacology: Cardiovascular safety assessments via implantable telemetry for continuous, real-time monitoring of ECG and hemodynamic parameters.
- Regulatory Toxicology Experts: Extensive experience in repeat-dose toxicology with comprehensive clinical pathology and histopathology endpoints.
- Integrated Toxicokinetics (TK) to provide a clear exposure-response relationship.
- Medical Device & Surgical Models: Evaluate the safety, performance, and biocompatibility of cardiovascular and orthopedic devices.
- On-Site Canine Colony with highly experienced veterinarians and AALAS-certified technicians providing best-in-class care.
- AAALAC-Accredited Facilities: All studies are conducted in a state-of-the-art, AAALAC-accredited vivarium, ensuring the highest standards of animal welfare and data integrity.
