Intertox, Inc. services

Food-borne illness strikes 48 million Americans each year; hospitalizing a hundred thousand and killing thousands. The Food Safety and Modernization Act of 2011 seeks to reduce these numbers by requiring growers to evaluate the hazards in their operations and implement measures to prevent contamination. Intertox has particular expertise in the specialty crop industry, relating to fruit, vegetables and tree nuts. In 2006, Intertox worked with the leafy green industry and a leading trade association, to develop best practices and food safety guidelines for leafy greens – a direct result of the E.coli outbreak in spinach. Intertox helped develop recommendations for reducing microbial contamination during production and harvest, along with testing strategies to detect microbial and chemical contamination. Since then, Intertox has worked on best practices for green onions, herbs and potatoes.

Nanotechnology holds great promise in the quest for better computers, electronics, medicine, medical devices, biomaterials and energy production. But like all new technologies, it also raises questions, such as the potential toxicity and environmental impact of nanomaterials and regulatory approval challenges.

Intertox scientists study the adverse effects in adult, infant or developing brain or nervous systems, such as visual and speech disturbances, delirium, convulsions, and encephalopathy.

Specialties in Neurological, Endocrinological, Reproductive, Developmental and Immunological Pharmacology and Toxicology. Assessments examine adverse effects on the developing brain or nervous systems, such as smell, visual and speech disturbances, convulsions, and encephalopathy. Assessments of the endocrine system deal with effects related to hormones or tissues that make them and include reproductive fitness and sexual behavior. Developmental toxicology studies adverse effects to the developing organism, such as birth defects, spontaneous abortion and behavioral deficits.

The Intertox team assists clients with both the science and strategy of the regulatory process at all levels, including federal, state and international requirements. Our work ranges from the Toxic Substances Control Act, Clean Water Act, and Proposition 65 in California to the Canadian Environmental Protection Act, Japan’s Chemical Substance’s Control Law and the Toxic Chemicals Control Act of South Korea.

Intertox works closely with attorneys and other technical experts to craft strategies on how to obtain the best scientific data to support or negate the scientific aspects of each case. We are particularly skilled at evaluating other experts’ scientific data and if merited, developing sound scientific support for attorneys. Our scientists advise on the technical merit of real or threatened lawsuits and testify on behalf of attorneys as requested.

Intertox’s multi-disciplinary team is adept at discovering the scientific basis of complex issues. We routinely conduct risk assessments to determine whether a suspected chemical or biological agent can cause the alleged health effect. This discovery allows clients to examine their case from various angles and can significantly strengthen a client’s legal position.

Intertox is often called upon to testify in depositions, arbitration and trials on behalf of both the defense and plaintiff. In each instance, Intertox adheres to objective examination of the evidence, and relies upon sound science to deliver its testimony.

Regulatory Submission – Prepare all regulatory approval documents in compliance with Common Technical Documents (CTD) requirements including electronic CTD (eCTD) submission to the FDA. Prior Approval Inspections – Assist with the preparation and participation in the FDA prior approval inspections, and oversee corrective actions as required. Labeling Negotiations – Negotiate with regulatory authorities regarding product labeling, advertising, and promotional materials.

Post-approval commitments – Support compliance with FDA post-approval commitments including CMC and Phase IV Clinical Trials. Post approval supplements – Manage regulatory strategic development, preparation, submission, and management of post-approval product modifications, including labeling, advertising and promotional materials.