In Vivo Toxicology and Safety Pharmacology Studies
Integrated preclinical toxicology, safety pharmacology, efficacy, pharmacokinetic (PK), and bioanalytical services designed to support IND-enabling drug development programs for biologics and other advanced therapeutics.
Accelerate IND Submission with Comprehensive Preclinical Toxicology Studies
IND-Enabling
Streamlined workflows and coordinated project management from study design through IND preparation.
Regulatory Expertise
Proven experience preparing regulatory packages and supporting IND filings, studies designed to support FDA, EMA, and NMPA submissions.
One-Stop Solution
One-stop integrated platform combining discovery, pharmacology, toxicology, regulatory, and CMC expertise.
Toxicology Study Services
Comprehensive Toxicology
- Single-dose toxicity studies to evaluate acute safety profiles.
- Dose-range finding (DRF) studies to establish optimal dosing parameters.
- Repeat-dose toxicity studies for chronic safety assessment.
- Topical toxicity studies for locally administered therapeutics.
- Safety pharmacology studies to evaluate effects on critical physiological systems.
- Tissue cross-reactivity analysis to assess off-target binding risk.
- Immunotoxicity assessments to characterize immune-related safety concerns.
Exclusive Benefits
- Expert Guidance: Up to 5 rounds of study design consultation and direct access to scientific experts.
- Faster Timelines: Priority scheduling and streamlined project execution.
- Dedicated PM Support: A single point of contact coordinating studies, CMC activities, and timelines.
- Regulatory Readiness: FDA-, OECD-, and NMPA-aligned support for IND-enabling programs and submissions.
- Cost Efficiency: Integrated services that reduce vendor management and internal resource demands.
Early NHP Toxicity
- Stable breeding program with 600-800 SPF-standard animals annually.
- Tissue Cross-Reactivity (TCR) evaluation for target safety assessment.
- Non-GLP single-dose and repeat-dose toxicology studies.
- Hematology and clinical chemistry analysis for comprehensive safety monitoring.
- Histopathological analysis, including Hematoxylin & Eosin (H&E), Immunohistochemistry (IHC), and Masson's Trichrome staining to assess tissue morphology, target expression, and fibrosis-related changes.
Resources
BROCHURE
Biologics Discovery Services Brochure
Tailored discovery strategies for diverse biologics modalities, designed to enhance success rates.
FLYER
In Vivo Pharmacology
Solutions including efficacy, biological Activity, DMPK, bioanalysis and toxicity.
WHITE
PAPER
Discovery of Functional Antibody Leads at Early Stage of Lead Screening
Solutions for antibody discovery platforms to overcome the limitations and improve efficiency of lead discovery.
FLYER
Powerdoma™: An Upgraded Hybridoma Platform
Making NHP PK studies more accessible for drug discovery.
Frequently Asked Questions