K2 Toxicology and Integrated Risk Assessment, LLC

K2 Toxicology and Integrated Risk Assessment, LLC — commonly branded as K2 Tox — is a specialized scientific consulting firm based in Las Vegas, Nevada, in the United States. The firm positions itself as a boutique consultancy delivering "science you can trust" and "insight you can act on," focused on toxicology, human health risk assessment, and regulatory strategy. Rather than manufacturing or selling physical products, K2 Tox sells expert scientific services: it helps clients interpret complex toxicological data, evaluate chemical and product safety, and prepare regulatory submissions. The company was founded by two board-certified toxicologists, Dr. Michael Kovochich and Dr. Daniel G. Kougias, who together bring more than 30 years of combined experience across academia, industry, and consulting. Their stated areas of recognized expertise include molecular toxicology, nanomaterial safety, reproductive and developmental toxicology, and chemical risk evaluation. The firm describes its client base as spanning consumer product companies, medical device manufacturers, pharmaceutical companies, regulatory agencies, and legal teams. K2 Tox's service portfolio covers predictive toxicology (using in silico tools such as QSAR, read-across, ToxTree, DEREK, and the OECD Toolbox), systematic literature review and weight-of-evidence analysis, regulatory science and product stewardship, exposure assessment and modeling, and nanotoxicology and emerging materials safety. Its regulatory work includes support for FDA submissions such as Premarket Tobacco Applications (PMTAs) and GRAS determinations, as well as EU Classification, Labelling and Packaging (CLP) and Medical Device Regulation (MDR) compliance support. The firm emphasizes a collaborative, data-driven approach and maintains a strong record of peer-reviewed publications. It is a privately held company and, as of the available evidence, operates primarily in the United States market. Its headquarters location in Las Vegas is confirmed by public company data.

K2 Toxicology and Integrated Risk Assessment, LLC was established as a boutique scientific consulting firm by two board-certified toxicologists, Dr. Michael Kovochich and Dr. Daniel G. Kougias. The founders brought more than 30 years of combined experience across academia, industry, and consulting, with recognized expertise in molecular toxicology, nanomaterial safety, reproductive and developmental toxicology, and chemical risk evaluation. Public company data places the firm in Las Vegas, Nevada, United States. From its founding, the firm has focused on translating complex toxicological and regulatory data into actionable insight for clients. Its client base has been described as ranging from consumer product companies, medical device manufacturers, and pharmaceutical companies to regulatory agencies and legal teams. The company has built its reputation on integrity, technical excellence, and a collaborative, data-driven approach. Over time, K2 Tox has developed a broad service portfolio. Its predictive toxicology practice applies in silico tools such as QSAR, read-across, ToxTree, DEREK, and the OECD Toolbox for early-phase screening of novel compounds and toxicological prioritization in data-poor environments. Its systematic literature review and weight-of-evidence practice provides structured review of toxicological, clinical, and epidemiological data, quantitative and qualitative weight-of-evidence frameworks, and regulatory-grade summaries and dossiers for litigation or submission. Its regulatory science and product stewardship practice supports FDA submissions including Premarket Tobacco Applications (PMTAs) and GRAS determinations, prepares safety dossiers and toxicology summaries, and provides EU Classification, Labelling and Packaging (CLP) and Medical Device Regulation (MDR) compliance support. Its exposure assessment and modeling practice uses tools such as IHSkinPerm and EPA algorithms, designs and interprets biomonitoring and passive dosimetry studies, and evaluates internal dose, dermal and inhalation pathways, and consumer and occupational exposure scenarios. Its nanotoxicology and emerging materials practice conducts safety assessments of engineered nanomaterials such as nanoparticles and carbon nanotubes. The firm maintains a strong history of peer-reviewed publications and regularly collaborates across disciplines. It remains a privately held company operating primarily in the United States market.

• Founded by Dr. Michael Kovochich and Dr. Daniel G. Kougias as a boutique toxicology consulting firm.

• Established headquarters in Las Vegas, Nevada, United States.

Boutique, science-first toxicology and risk assessment consultancy serving industry, regulators, and legal teams.

• Predictive Toxicology

  Application of in silico tools (e.g., QSAR, read-across, ToxTree, DEREK, OECD Toolbox) for early-phase screening of novel compounds and toxicological prioritization in data-poor environments.

• Systematic Literature Review & Weight-of-Evidence Analysis

  Structured review of toxicological, clinical, and epidemiological data; quantitative and qualitative weight-of-evidence frameworks; regulatory-grade summaries and dossiers.

• Regulatory Science & Product Stewardship

  Support for FDA submissions including Premarket Tobacco Applications (PMTAs) and GRAS determinations; EU CLP and MDR compliance support.

• Exposure Assessment & Modeling

  Exposure modeling using tools such as IHSkinPerm and EPA algorithms; biomonitoring and passive dosimetry study design and interpretation.

• Nanotoxicology & Emerging Materials

  Safety assessments of engineered nanomaterials (e.g., nanoparticles, carbon nanotubes).

1. 1Toxicology Consulting & Human Health Risk Assessment | K2 Toxk2tox.com
2. 2About K2 Tox | Board-Certified Toxicology Consultantsk2tox.com
3. 3Toxicology Consulting Services | Risk Assessment, Predictive Toxicology, Exposure Sciencek2tox.com
4. 4K2 Toxicology and Integrated Risk Assessment, LLC - Wikidatawikidata.org