Product Safety Assessment and Product Stewardship

Dr. Brock has extensive experience in characterizing the intrinsic hazards of a wide variety of substances used in the consumer product, pharmaceutical and chemical industries. Our clients have benefited from our safety assessments and the development of product stewardship programs.

We have prepared dose-response assessments for use in risk analyses and prepared hazard reviews for regulatory submissions for new chemicals and documentation for defense of existing substances. We have:

	Extensive experience in the design, placement, monitoring and reporting of a wide-variety of toxicology studies and programs including acute, subchronic, chronic and carcinogenicity, developmental and reproductive toxicology neurotoxicology and genetic toxicology
	Designed and monitored specialized toxicology studies such as pharmacokinetic and mechanistic studies necessary to satisfy various regulatory issues or for product defense
	Initiated and managed occupational toxicology programs including epidemiology assessments.
	Prepared Material Safety Data Sheets and product specific brochures for many compounds and process intermediates
	Implemented product stewardship programs, and prepared product stewardship plans for new and exiting products
	Prepared documentation for setting occupational exposure limits for a wide variety of chemicals, and defending those limits to international regulatory authorities
	Implemented industrial hygiene programs to ensure compliance with established exposure limits

Regulatory Toxicology

Brock Scientific Consulting, LLC has identified numerous regulatory and technical issues that could potentially affect product development and commercialization. We have prepared:

	Risk assessments and comprehensive reports for pharmaceutical, industrial, agricultural and environmental agents, food substances in response to Proposition 65 determinations.
	New chemical notifications dossiers for submission to the European Union (EU), Japan 's MHLW and the Korean inventory.
	Hazard and risk summaries for pre-manufacturing notification for TSCA
	EPA registration and re-registration of pesticides under FIFRA
	Notifications to the FDA for pharmaceuticals, medical devices and food products