Environmental Risk Assessment for Pharmaceuticals
Requirements for evaluating the environmental impacts of human and veterinary medicines as part of the drug approval process exist across a number of regulatory agencies in North America, Europe, and Asia. Exponent has expertise in all aspects of conducting environmental risk assessments for pharmaceuticals including evaluating fate and transport properties, developing exposure scenarios, assessing ecological effects on non-target organisms, and calculating risk for all potentially affected environmental compartments. Our scientists are also involved in the global dialogue surrounding the detection of trace concentrations of pharmaceuticals in surface water and drinking water and the related issues of potential treatment, risk, and regulation.
Exponent scientists can assist pharmaceutical and biotechnology companies in meeting the growing requirements for U.S., E.U., and worldwide product approvals and product defense. Our environmental risk assessment consultants have provided valuable support and assistance to clients at every step, from initial strategy development through placement and monitoring of studies, preparation of the environmental assessment, and regulatory negotiations. Our experience includes complex issues involving nanotechnology, endocrine disruptors, and genetically modified organisms, as well as traditional pharmaceuticals.
Environmental Risk Assessment Services
- Strategy development and negotiation
- Literature search and critical review
- Justification for categorical exclusion
- Data gap analysis
- Study placement, monitoring, and evaluation
- Physico-chemical properties
- Environmental fate
- Field studies
- Environmental Assessment (EA) for submission to U.S. FDA
- Per Guidance for Industry CMC 6 (CDER and CBER) and 89 and 166 (CVM)
- Environmental Risk Assessment (ERA) for submission in Europe
- Per EMEA CHMP and CVMP guidance
- Environmental Risk Assessment (ERA) for submission in other jurisdictions
- For example, per Canada’s Environmental Impact Initiative
- Preparation for and representation at regulatory agency meetings
- Risk communication.