We have experience in working with all relevant models to derive predicted environmental exposure values in different compartments.
Environmental Exposure Assessments
For environmental exposure assessments, we use a number of models including those which are recognised from the FOCUS group (Forum for the coordination of pesticide fate models and their use). The use of these models enables us to characterise substance properties that are relevant to their environmental fate and estimate the predicted environmental concentration (PEC) in soil, groundwater, surface water and air. The PEC values calculated are used by us to perform ecotoxicological risk assessments based on characterisation of exposure and effects.
These PEC calculations are conducted using a powerful server-based simulation environment together with efficient data extraction software, enabling us to investigate a huge number of combination of substance properties, application timings, uses and scenarios.
Ecotoxicological Risk Assessments
We perform ecotoxicological risk assessments according to current guidance documents and regulations and also take into consideration recent developments in the regulatory framework of the European Union and the rest of the world. The development of strategies for environmental risk assessments based on the results of higher tier studies on community level or under complex exposure conditions becomes more and more important and is also part of our teams approach concerning environmental fate and ecotoxicological aspects.
Environmental Risk Assessment (ERA) for Pharmaceuticals
We have been conducting environmental risk assessments (ERA) for pharmaceuticals since the first version of the guideline on the environmental risk assessment of medicinal products for human use was adopted in 2006 (EMEA/CHMP/SWP/4447/00 corr 2). With this vast experience our team of biologists, pharmacists, (eco)toxicologists and chemists is well prepared for the challenges which might come with EMA's revision of the ERA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1).
- Environmental risk and exposure assessments for all types of products and chemicals
- PBT assessment (persistence, bioaccumulation and toxicity)
- Tailored risk and exposure assessments for pharmaceuticals with specific classification, e.g. endocrine active substances and antibiotics
- Study planning and monitoring of all kind of studies required in the context of an environmental risk, exposure and/or PBT assessment (ecotoxicity, toxicology, fate and behaviour and physical chemistry)
- Derivation of the Environmental Quality Standards (EQS) and the German water hazard classes (Wassergefährdungsklassen, WGK).