Welcome to AI Engineered Toxicology

Our Services

Nonclinical Program Design: We design efficient, science-driven nonclinical toxicology safety assessment programs tailored to your compound and target indication. Our AI Engineered Toxicology approach is preferred because we combine 40 years of Big Pharma executive experience with proprietary AI toxicology evaluations to optimize study packages that accelerate regulatory approval strategies while minimizing unnecessary studies.

Study Design, Monitoring, and Interpretation: We offer expert design, placement, and oversight of GLP and non-GLP toxicology, safety pharmacology, and ADME studies at leading CROs. Clients choose us for our ability to integrate AI-powered predictive insights with real-world regulatory experience, resulting in clearer data interpretation and faster decision-making in pharmaceutical consulting.

Histopathology Peer Review: We provide independent peer review of GLP toxicology studies. Our AI Engineered Toxicology services are preferred because we have over 20 years of senior-level experience conducting histopathology peer reviews. Our expertise includes extensive direct interactions with regulatory agencies (FDA, EMA, and others), where we travel to present and defend study findings. Unlike most CRO pathologists who have limited interaction with regulatory agencies, we understand how subtle nuances of diagnosis can significantly affect regulatory authorities’ interpretation. Accurate determination of NOAELs is especially critical, as it directly impacts clinical starting doses and significantly affects the overall timing of drug development.

Regulatory Document Preparation and Submission Support: We expertly prepare and defend high-quality IND, NDA, BLA, CTD, and other regulatory dossiers. Our team is preferred because we have successfully authored or reviewed dozens of submissions across FDA, EMA, and global authorities, utilizing AI to strengthen arguments and reduce queries in regulatory approval strategies.

Due Diligence Review for In-Licensing: We conduct thorough, rapid evaluations of in-licensing candidates with focused nonclinical safety risk assessments. Clients select AI Engineered Toxicology for our proprietary AI database and decades of licensing experience, which provide clear, actionable recommendations that support confident and timely deal decisions.

Expert Guidance for Smooth Regulatory Discussions

With over 40 years of experience in nonclinical toxicology, I prepare and defend toxicology packages for major pharmaceutical companies, helping sponsors navigate FDA interactions efficiently and confidently. My expertise is further enhanced by AI toxicology evaluations, which provide rapid access to precedent data from hundreds of FDA, EMA, and PMDA reviews. This allows us to strengthen your case with real-world regulatory examples.

Specific Ways I Support Your FDA Interactions

- Prepare Pharmacology/Toxicology sections for Pre-IND briefing packages with clear, data-driven justifications for species selection, study duration, safety margins, and waivers (ICH S9, S6(R1), M3(R2)).

- Draft targeted questions for Pre-IND meetings that focus FDA feedback on the critical issues for your FIH-enabling toxicology program.

- Develop regulatory approval strategies and gap analyses based on approved comparators in the same modality or therapeutic class.

- Review and strengthen your proposed toxicology plan to minimize the risk of clinical holds.

- Provide independent, experienced input during meeting preparation and post-meeting response strategy.

Result: You enter FDA meetings with stronger scientific rationale, clearer precedent support, and greater confidence in your toxicology package, backed by comprehensive pharmaceutical consulting.