Environmental Risk Assessment

The Environmental Risk Assessment (ERA) service from Charles River is based on European guidelines; however, it can be applied to other submissions in differing countries and regulatory agencies. We have experience in ERA for all industry product sectors, including human pharmaceuticals.

ERA Program Design Considerations

We have extensive experience in ERAs for human pharmaceuticals, including ERAs and EAs accepted by the EMA and FDA. 
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ERA is conducted in two phases:

  • Calculates the Predicted Environmental Concentration in surface water (PECSURFACEWATER) of the active substance and relevant metabolites.
  • If PECSURFACEWATER exceeds a set action limit, or if an expert evaluation of preclinical safety and ecotoxic potential suggests a possible environmental concern, then a Phase II environmental fate and effects analysis should be performed.
  • Tier A – generation of a base set of laboratory data to assess physical-chemical properties, environmental fate and aquatic effects of the substance.
  • Tier B – extended evaluation of environmental fate and effects, triggered if Tier A results indicate a risk to the environment and may include bioaccumulation, sediment and soil organism testing.

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Regulatory Consulting

Regulatory Consulting

Areas of expertise include pharmaceuticals, biologics, medical devices, veterinary medicines and agrochemicals.

Webinar Replay

Webinar Replay

Applications for drug approvals in US and European markets must include a complete environmental risk assessment. In this first of a two-part webinar series, we outline the regulatory requirements that will impact your ERA program design.

ERA Case Study

Assessment of the environmental fate and effects of the PPARgamma receptor agonist, pioglitazone.