
Regulatory
Science
Certain chemicals, such as pharmaceuticals or pesticides, are strictly
regulated by federal and/or state agencies in the US. I bring experience in US and international regulatory ecosystems to help my clients navigate the technical portfolio needs of their chemical products and subsequently the regulatory application process. In particular I can help with EPA registration applications for pest control agents and pre-clinical toxicology for FDA Investigative New Drug (IND) applications.
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A vast range of industrial chemicals are largely unregulated or regulated only in workplace settings. For these latter classes of chemicals, the burden of demonstrating harm to human or animal health falls to harmed parties through the legal process. I provide hazard identification and assessment to determine the likelihood of harm from chemical exposures. Reliable safety assessments are critical in the context of consumer product exposure as well as environmental exposures in the context of environmental justice issues.