Toxicology Services

Overview

Endpoint Preclinical’s Toxicology services provide comprehensive support for medical devices, drug-device combination products, and pharmaceuticals — from early feasibility studies through regulatory submission and market access. This service ensures that safety, efficacy, and regulatory requirements are integrated seamlessly across the preclinical program.

Our expertise spans GLP and non-GLP toxicology, biocompatibility, extractables & leachables, risk assessments, and regulatory consulting. By combining deep scientific insight with practical experience in product development, we help clients navigate complex regulatory landscapes, design efficient study programs, and generate the cohesive datasets required for approval and adoption.

Study oversight
Biocompatibility & materials assessment
E/L analysis
Risk assessment & regulatory support

Study oversight
Biocompatibility & materials assessment
E/L analysis
Risk assessment & regulatory support

Service Highlights

Below is a selection of our toxicology consulting capabilities. If you don’t see exactly what you need, please contact us — we can likely tailor a solution for your program.

Integrated Preclinical Program Design: Development of end-to-end preclinical strategies that align with regulatory expectations and market goals. Emphasis on designing efficient, tailored study sequences that reduce redundancy, optimize resources, and accelerate timelines.
Biocompatibility & Materials Assessment: Strategic planning and interpretation of biocompatibility studies for implantable, interventional, and combination products. Guidance on material selection, coatings, sterilization impacts, and ISO 10993 compliance ICH and other global standards and regulations.
Extractables & Leachables (E/L) Analysis: Development and oversight of E/L strategies to identify, quantify, and assess potential leachables from device materials, packaging, and processes. Integration of analytical findings with toxicologic risk assessment to meet FDA, EMA, and global expectations.
Toxicology Study Oversight: Design and oversight of GLP and non-GLP studies, including systemic toxicity(acute/chronic), local tolerance, genotoxicity, sensitization, and implantation models. Emphasis on integrating study results into cohesive safety datasets for regulatory use.
Risk Assessment & Hazard Evaluation: Extensive experience in health hazard assessments, toxicologic risk evaluations, and risk communication. Application of methodologies to evaluate device safety and ensure compliance with international regulatory frameworks.
Regulatory Strategy & Submission Support: Direct support for IDE, IND, NDA, PMA, and 510(k) submissions, as well as EU and global equivalents. Preparation of toxicology sections, responses to regulatory queries, and participation in meetings with FDA and international authorities.
Data Integration & Reporting: Synthesis of imaging, clinical chemistry, pathology, and PK data into decision-ready reports and risk/benefit narratives. Ensures study results are translated into regulator-ready deliverables that support efficient approvals.

Meet our Toxicology Expert!

David W. Eaker, PhD, DABT

Expert in Toxicology, Preclinical Strategy, and Regulatory Affairs. View Profile

Why Endpoint?

Toxicology is a critical bridge between innovation and market access. Endpoint Preclinical provides clients with insight into how toxicology integrates into broader preclinical and regulatory programs, combining rigorous scientific evaluation with practical, product-focused strategy.

Our approach ensures that each study not only meets compliance requirements but also contributes to a cohesive integrated evidence package. By embedding toxicology expertise within our broader network of preclinical services, we help clients navigate complexity, mitigate risk, and accelerate safe, responsible innovation.

Toxicology Services