VxP Pharma Preclinical offers a complete range of in-vivo and in-vitro preclinical safety evaluation studies. We have a long history of providing flexible solutions, accelerated timelines and supporting both cGLP and non-cGLP laboratory services that meet or exceed global regulatory standards/guidelines. We have conducted multiple IND and NDA enabling studies for submission to the US FDA and other global regulatory authorities, and with this experience, we can offer invaluable guidance as you move your project forward.
- Med Device including surgical models
- Drug-Device Combinations
- Acute / Sub-chronic / Chronic Toxicology
- Dose Range Finding (DRF)
- Development & Reproductive Toxicology (DART)
- Dermal Toxicology
- Ocular / Ophthalmic Toxicology
- Pathology / Clinical Pathology
- DMPK / ADME Studies (in vivo/in vitro)
- Immunology / Biomarkers
- Medical Device Biocompatibility including ISO 10993 Testing
- Regulatory consulting for med device programs
- Early Tox Formulation Development
Wherever your endpoint might be, VxP can help you get there.