Non-Clinical Services
From Preclinical Data to Global Approvals—Strategic, Compliant, Submission-Ready
Regulatory success begins long before clinical trials.
At ToxExel Solutions, we transform non-clinical (preclinical) data into clear, compliant, and submission-ready regulatory packages aligned with global regulatory agency expectations.
Our Core Non-Clinical Regulatory Services
IND-Enabling Strategy & Documentation
- Non-clinical development strategy
- Study gap analysis and planning
- Preparation of non-clinical sections for IND submissions
CTD Module Writing (Modules 2.4 & 2.6)
- Non-clinical Overview (Module 2.4)
- Non-clinical Summaries (Module 2.6)
- Integration of pharmacology, pharmacokinetics, and toxicology data
Regulatory Gap Assessment
- Evaluation of existing data against regulatory expectations
- Identification of missing studies or scientific justifications
- Strategic recommendations to address regulatory gaps
Study Design & Regulatory Guidance
- Toxicology study design aligned with regulatory guidelines
- Species selection, dosing strategy, and endpoint recommendations
- Support for GLP and non-GLP studies
Regulatory Submission Support
- Support for United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and global regulatory agencies
- Responses to regulatory queries
- Deficiency letter support and remediation guidance
Integrated Non-Clinical Data Review
- Cross-functional review of pharmacology, pharmacokinetics (PK), and toxicology data
- Identification of inconsistencies, risks, and data gaps
- Development of a unified regulatory narrative
Regulatory Alignment
Our non-clinical services are aligned with:
- International Council for Harmonisation (ICH) guidelines including M3, S Series, and Q Series
- United States Food and Drug Administration (FDA) regulations
- European Medicines Agency (EMA) requirements
- Organisation for Economic Co-operation and Development (OECD) GLP Principles
- Global regulatory compliance frameworks