Environmental Risk Assessments
Evaluating a pharmaceutical’s potential environmental impact requires expertise in both drug development and environmental testing
Eurofins Regulatory Science Services’ environmental risk assessment (ERA) testing capabilities for human and veterinary pharmaceuticals provide the environmental data and guidance you need to meet testing and timing requirements.
As partners with pharmaceutical and animal health companies, Eurofins also has a long history of supporting drug development through a deep understanding of global regulatory requirements for environmental submissions and can guide you through the assessment process with accurate timelines.
Eurofins Regulatory Science Services will help you get started at the optimal time to avoid submission delays. With environmental risk assessment studies taking 10 to 12 months—or longer—our program managers and scientific advisors will guide you to successful completion.
Eurofins’ industry leadership in chemical registration support is based on our more than 120 years of combined laboratory experience in studies involving environmental fate, ecotoxicology, plant and animal metabolism and product chemistry, our scientists design and execute the right experiments to produce quality data.
Our environmental risk assessment studies, or ERA for pharmaceuticals capabilities include:
- Evaluation of testing needs
- Aquatic Safety Studies
- Terrestrial Safety Studies
- Avian Safety Studies
- Metabolism
- Environmental fate
- Product chemistry
- Method development/method validation
- Document preparation
- Categorical exclusions
- FDA-CVM Environmental Assessments
- FDA-CDER Environmental Assessments
- EMA Environmental Risk Assessments