Pharmaceutical Toxicology, Strategy, & Development Consulting Services

Regulatory toxicology is the science of evaluating the safety of substances—including pharmaceuticals, chemicals, food ingredients, cosmetics, and consumer products—to meet the requirements of government agencies such as the United States Food and Drug Administration (FDA), the United States Environmental Protection Agency (EPA), the European Medicines Agency, and Health Canada. It provides the safety data that regulatory authorities require before a product can enter clinical trials, reach the market, or maintain its registration. If a sponsor does not conduct a rigorous toxicological evaluation for its product before applying for agency approval, the product may face regulatory delays, clinical holds, or rejection. Intertek Assuris provides regulatory toxicology consulting for the pharmaceutical industry, backed by more than 30 years of experience and a team of qualified subject matter experts, including board‑certified toxicologists (DABTs).

Good Laboratory Practice (GLP) studies ensure data integrity, traceability, and reproducibility of results by following strict regulatory standards established by the FDA, the EPA, the Organisation for Economic Co‑operation and Development, and other agencies. GLP studies are critical nonclinical studies included in formal regulatory submissions, such as Investigational New Drug (IND) New Drug applications and Biologics License Application submissions to the FDA. Intertek Assuris provides expert study monitoring and strategic guidance for both GLP and non-GLP toxicology studies.

An IND application is a formal request submitted to the FDA that allows a sponsor to begin clinical trials of a new drug in humans. The initial IND application contains data to demonstrate that the proposed clinical investigation is reasonably safe and includes summaries of chemistry, manufacturing, and controls (CMC) data; nonclinical pharmacology, pharmacokinetics, and toxicology study results; all available clinical data; the proposed clinical protocol for the initial study; and an investigator’s brochure. Once the IND is active, sponsors will continue to submit additional data, amended protocols, and clinical study results throughout the drug development lifecycle. Intertek Assuris supports sponsors with IND‑enabling nonclinical strategy, regulatory writing, and electronic common technical document (eCTD) publishing to ensure a complete and organized IND application.

An initial IND application typically requires a package of nonclinical safety studies such as pharmacokinetic evaluations, repeat–dose toxicity studies, genotoxicity studies, and safety pharmacology assessments. The specific requirements will depend on the therapeutic modality (e.g., small molecule, biologic, gene therapy), the proposed clinical indication (e.g., oncology), the duration of clinical dosing, and the patient population. Intertek Assuris provides end-to-end IND‑enabling strategy development and execution, from study designs and monitoring to regulatory writing and eCTD publishing.

NOAEL stands for “no-observed-adverse-effect level” and refers to the highest dose of a substance at which no statistically or biologically significant adverse effects are observed in a toxicology study [ICH M3(R2)]. It is determined through systematic evaluation of study endpoints across multiple dose groups in a study. The NOAEL is a critical value for products that have not been clinically tested because it can serve as the basis for calculating human safety margins and starting doses for clinical trials. Intertek Assuris’ subject matter experts can review data to confirm NOAELs declared in nonclinical studies and use NOAELs to establish proposed starting dose levels in first‑in‑human clinical studies.

Safety pharmacology evaluates the potential for a drug candidate to produce undesirable pharmacodynamic effects on the major organ systems. The core battery of studies assesses the cardiovascular system (e.g., QT prolongation, hemodynamic changes), respiratory system (e.g., tidal volume, respiratory rate), and central nervous system (e.g., behavioral, neurological function). These studies provide critical data for risk assessment and clinical monitoring plans, and these are typically required before first-in-human clinical trials per ICH S7A. Safety pharmacology findings influence clinical trial design, dose selection, and go/no‑go decisions. Intertek Assuris’ pharmaceutical team provides strategic guidance on safety pharmacology study design, species selection, and regulatory interpretation across small molecules, biologics, and advanced therapeutic modalities.

Timelines vary significantly by program complexity, but a typical small-molecule, IND-enabling toxicology program takes 9 to 16 months from initial study design to IND submission. This includes dose range–finding studies, GLP repeated–dose studies of appropriate duration (typically 28 days for studies supporting clinical Phase 1, but this depends on study design), genotoxicity testing, safety pharmacology, and report preparation and regulatory writing. Biologics, gene therapies, or combination product programs may take longer due to additional specialized assessments. Intertek Assuris helps clients optimize their critical path by providing an integrated toxicology strategy plan, study monitoring, report and data review, document drafting, regulatory affairs, and eCTD publishing under one roof, eliminating handoff delays between multiple vendors.

Biologic products—including monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs), and cell therapies—require nonclinical programs that differ substantially from small molecules. Key considerations include species selection based on pharmacological relevance, immunogenicity assessment, cytokine release assays, tissue cross-reactivity studies, and modified study designs. Intertek Assuris has expertise in nonclinical strategy for biologics, ADCs, and plasmacytoid dendritic cells, helping sponsors navigate the unique regulatory expectations for these therapeutics.

Yes! Toxicologists have specialized expertise in designing nonclinical drug development programs that strategically align with your product and represent your interests. Intertek Assuris’ toxicologists design nonclinical programs that consider your entire data package, including your CMC and clinical programs, to ensure a cohesive and efficient path to regulatory submission. Our toxicologists also work directly with sponsors and Contract Research Organizations to troubleshoot issues, write and interpret data with integrity, and integrate these data into regulatory submissions.

With DABTs and decades of experience, Intertek Assuris has successfully guided clients through their programs from early drug discovery to the first-in-human trial, and beyond.