Environmental risk assessment (ERA)

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 consisting 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).

Our services

- Environmental risk assessments (Module 1.6.1), including
        
- PBT assessment (persistence, bioaccumulation and toxicity)
        - Tailored risk assessments for substances 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 and/or PBT assessment (ecotoxicity, toxicology, fate and behaviour
           and physical chemistry)

- Support with product information text in the context of the environmental risk assessment

- Derivation of the Environmental Quality Standards (EQS) and the German water hazard classes
  (Wassergefährdungsklassen, WGK)