Intertox has extensive experience working with federal, state and local regulatory agencies. The firm’s success in working with regulatory groups is based on established relationships with key personnel and the excellent technical reputations of Intertox scientists. Intertox has been instrumental in obtaining regulatory approval of innovative approaches to risk assessment, alternative points of compliance, and alternative exposure factors on behalf of clients.
Development and Regulatory Services
The Development and Regulatory Services unit provides comprehensive regulatory affairs consulting services with an emphasis on medical products, including medical devices, pharmaceuticals, and a combination of other products. We provide flexible, personalized, cost-effective services to assist clients in the development and implementation of successful, rapid, marketing authorization programs. Services include regulatory strategic planning and oversight of all applicable product development functional areas to ensure compliance with FDA regulations and guidelines governing the development and licensure of medical products.
Support for Regulatory Decision
Intertox recently assembled a diversely experienced team of science, policy, and economics experts to support governmental and industrial entities collaborating to advance U.S. EPA’s development of a scientifically sound reference dose for perchlorate. The unifying thread of all Intertox efforts was constant emphasis on best serving public interest by characterizing and applying the best available science.
Specific scientific efforts related to this work have included critical analysis of scientific studies and reports produced or relied upon by U.S. EPA in developing draft reference dose estimates; synthesis of technical information for translation to lay audiences; development of alternative reference dose estimates based on scientifically sound and appropriate data not considered by U.S. EPA; and development of comparative risk analyses to relate the magnitude of exposure from perchlorate in terms of common, everyday exposures. Regulatory policy efforts have included arguments for adherence to internal regulatory requirements and data quality standards and continued education of government officials and entities interested in furthering the acceptance of the best available scientific basis for the perchlorate reference dose.
Compliance Negotiation
In another example, Intertox appeared before the California-OSHA Air Contaminants Advisory Committee to testify about the scientific basis of an excessively restrictive proposed standard for worker exposure during installation of cellulose insulation products. Intertox’s assessment included an extensive review of toxicological and health effects literature related to the suspected agents of concern—soft-paper dust, wood dusts, and toxigenic fungi—to provide scientifically accurate information that was presented in testimony.
Scientific Expertise for Product Development
Intertox was successful in registering a flea control pesticide in California, which the State had previously suspended due to lack of required animal studies on chronic effects. Intertox staff negotiated a non-human alternative dosimetry study to estimate dermal absorption and demonstrate product safety.