Environmental Risk Assessment
Assessing the environmental impact of your human or animal medicines
For the marketing authorization of new and generic medicinal or veterinary products, an environmental (risk) assessment is generally required in the European Union, in the United States of America and in several other countries.
EAR are offers dedicated consulting services for Environmental Risk Assessment according to the recent requirements of the European Medicines Agency (EMA) and U.S. FDA. Depending on your needs, our consultancy can include all steps from the planning of the project until the risk assessment expert report and beyond to deliver cost-effective and timely solutions depending on your regulatory needs.
EAR experts are advising pharmaceutical and veterinary products industry to make sure their innovative products will get their marketing authorizations:
- Data gap analysis, i.e. cost and time analysis of the required testing program
- Environmental risk assessment including refinements, if required
- Preparation of the Expert report and Expert assessments, e.g. PBT (Persistency, Bioaccumulation and Toxicity) classification, or environmental testing programs for API’s with endocrine activity
- Literature search and compilation of published environmental data including quality evaluation
- Study monitoring, i.e. study planning and peer review of draft study plans and reports of the environmental studies
- Stewardship through the evaluation process
- Project management
Complementary to the consulting services, Eurofins Agroscience Services (EAS) can provide the full range of environmental testing services required for your marketing authorization application of your medicinal product.
Our promise to you:
Your ideal partner for a fully compliant environmental risk assessment data package for your marketing authorization application.
For further information, please contact us