Defensible risk assessments for highly regulated products

ToxPharm provides science-driven toxicological risk assessment and regulatory support for complex and emerging products. We translate toxicological and exposure data into clear, regulator-ready conclusions that support product development, market access, and long-term compliance.

 
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What We Do

ToxPharm supports informed, risk-based decisions through:

  • Toxicological risk assessment & safety strategy

  • Nicotine, tobacco & cannabis product support

  • Genotoxicity & hazard evaluation for ingredients

  • Exposure and use-based safety assessment

  • Regulatory and scientific advisory services

All work is fit-for-purpose, defensible, and aligned with regulatory expectations.

 

Ingredient Toxicology Evaluations (Ingredient Profiles)

ToxPharm provides ingredient-level toxicological evaluations to support regulatory submissions, product development, and safety decision-making for highly scrutinized products. Our assessments are built using a weight-of-evidence approach consistent with recent scientific and policy communications from the FDA Center for Tobacco Products (CTP).

Ingredient profiles integrate all relevant data streams to arrive at clear, defensible safety conclusions, even when traditional toxicology data are limited or unavailable.

Our approach includes:

  • Weight-of-evidence evaluation integrating available in vitro, in vivo, human, and regulatory data

  • Use of computational toxicology (QSAR) to inform hazard identification and support data-gap assessment

  • Read-across and analogue-based justification for structurally related compounds with limited or no toxicity data

  • Evaluation of genotoxicity and carcinogenicity potential using tiered, risk-based frameworks

  • Transparent documentation of assumptions, uncertainties, and scientific rationale aligned with FDA CTP expectations

ToxPharm’s ingredient evaluations are designed to be regulator-ready, scientifically robust, and clearly articulated-supporting PMTA, Substantial Equivalence, and ingredient reporting pathways while enabling informed internal decision-making.

 
 

In Vitro Toxicology Expertise

Study Design & Scientific Oversight

ToxPharm designs and manages in vitro toxicology strategies that generate meaningful, regulator-relevant data. We provide independent oversight of external laboratories and ensure studies are scientifically robust and appropriately interpreted.

Experience includes:

  • Cytotoxicity testing

  • Genotoxicity assays (e.g., micronucleus, Ames)

  • Dose-setting and acceptance-criteria strategy

  • Integration of results into risk assessments and regulatory narratives

 

PMTA & Substantial Equivalence Support

ToxPharm provides independent toxicology and regulatory science support for Premarket Tobacco Product Applications (PMTAs), Substantial Equivalence (SE) submissions, and responses to U.S. Food and Drug Administration (FDA) deficiency questions.

We help clients navigate the most scientifically scrutinized aspects of tobacco and nicotine product review by delivering clear, defensible toxicological assessments aligned with FDA expectations.

Our support includes:

  • Toxicology strategy and data interpretation for PMTA and SE pathways

  • Ingredient-level risk assessment and hazard evaluation

  • Comparative and bridging assessments to support substantial equivalence determinations

  • Scientific review and response support for FDA deficiency and information requests

  • Regulator-ready toxicology narratives that integrate exposure, hazard, and weight-of-evidence

 

Let’s Work Together

If you need toxicological support, defensible safety assessment, or regulatory strategy, ToxPharm is ready to help.

Contact us to schedule a meeting

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