Successful navigation of the environment in which chemical products and processes are regulated requires knowledge of the underlying science associated with each chemical.  A thorough understanding of the conditions under which toxicity may occur allows for the development of risk estimates that minimize uncertainties and default assumptions. IB moves beyond standard risk assessment methodology to incorporate molecular, pharmacologic, and mechanistic information to develop successful strategies based on as complete an understanding of hazard, dose-response, and exposure as possible given the available data.  This allows for risk characterizations that are transparent, data-rich, and consistent with statutory guidance.   In addition to mastery of the science, successful product development and stewardship requires facility with the regulations governing manufacture, distribution, and disposal resulting in occupational, consumer, and environmental exposures. IB has been involved in interpreting and operating under the key legislative and statutory actions that have been promulgated in the last 20 years.  Its work has dealt with compliance with federal, state and international regulatory concerns.

Regulations have been developed for various products regulated by FDA and manufacturers must comply with both the pre-market and post-market provisions.  IB has experience dealing with the regulations that pertain to all classes of FDA-regulated products.  No matter how much planning goes into development of a new product, including extensive documentation of the safety and efficacy of the product, it is impossible to predict what issues may arise, either during development or once the product is marketed.