Non-Clinical Development & Preclinical Strategy Services
We provide comprehensive toxicological evaluations to ensure product safety, regulatory compliance, and successful global submissions.
At ToxExel Solutions, our consulting team supports the design, monitoring, interpretation, and reporting of toxicology studies to help pharmaceutical, biotechnology, and CRO organizations achieve regulatory success with confidence.
We have a dedicated team of highly qualified, experienced American Board-certified Toxicologists (DABT) and European Registered Toxicologists (ERT) with more than two decades of experience in the pharmaceutical and CRO sectors.
Our Core Expertise & Services
Study Design (GLP & Non-GLP)
- Review of study plans, protocols, and reports
- Alignment with study objectives, test guidelines, and animal ethics requirements
- Scientific oversight by Board-certified Toxicologists (DABT) and Pathologists (DIBTP, DICVP)
CRO Selection & Monitoring
- CRO selection and qualification support
- Monitoring of critical study phases in accordance with OECD GLP requirements
- Vendor evaluation and Quality Management System (QMS) audits on behalf of sponsors
- Liaison support between sponsors and CROs for effective study execution
Integrated Toxicology Programs
- Integrated non-clinical development strategies
- DART (Developmental and Reproductive Toxicology) planning
- Genotoxicity and carcinogenicity program support
- Safety pharmacology and ADME integration
Data Gap Analysis & Bridging Strategies
- Identification of scientific and regulatory gaps
- Bridging strategies to support product development
- Full scientific support throughout the product development lifecycle
Animal Models & In Vitro Testing Support
We support both small animal and large animal toxicology studies, including:
Small Animal Models
- Rats
- Mice
- Guinea pigs
- Rabbits
Large Animal Models
- Beagle dogs
- Sheep
- Goats
- Pigs
- Cattle
In Vitro Testing Services
- Cell-based toxicology support
- In vitro screening and evaluation services
- Regulatory-aligned alternative testing approaches
Ready to Strengthen Your Non-Clinical Development Strategy?
Partner with ToxExel Solutions for expert toxicology consulting, regulatory guidance, CRO oversight, and end-to-end preclinical development support.