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. 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 also 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, genotoxicity, developmental and reproductive toxicology and neurotoxicology studies. In addition we have designed and monitored specialized studies, including safety and efficacy pharmacology studies necessary to satisfy various regulatory issues.

Dr. Brock initiated and managed the occupational toxicology programs including some aspects of epidemiology assessments. We have prepared Material Safety Data Sheets and product specific brochures and labels for finished products and process intermediates. We have been very active in setting occupational exposure limits for a wide variety of substances including pharmaceuticals, chemicals, intermediates, etc. and defending those limits to various international regulatory authorities.

	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

Dr. Brock has performed numerous risk assessments and prepared comprehensive reports for pharmaceutical, industrial, agricultural and environmental agents, food substances and risk analyses for Proposition 65 determinations.

We have prepared and assisted clients in submitting new chemical notifications to the European Union (EU). We have also prepared hazard and risk summaries for pre-manufacturing notification (PMN) for TSCA.

Dr. Brock has prepared IUCLID dossiers for EPA’s HPV program and working with clients on developing dossiers and risk assessments for REACH.

We also have prepared notifications for registration of chemicals for Japan and Korea, and are familiar with the process of notifications being developed in other Asia-Pacific region countries.

	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