For the registration of your Pharmaceutical Product under the EMEA 2006 Guideline and the related Technical Guidance Document (TGD) we support you with the following services:

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• Phase I: Estimation of Exposure:

  • PEC surface water, basic calculation and refinement of FPEN

  • TGD waste water and dilution estimates, further determination of PEC surface water

• Phase II: Environmental fate and effects analysis, TIER A: Initial EFAEA

  • Study evaluation and summary

  • Deriving PNEC values

  • Evaluation of PEC/PNEC ratio from base data set

• Phase II: Environmental fate and effects analysis, TIER B: Extended EFAEA

  • Determination of PEC STP, PEC surface water, PEC sediment, PEC soil, PEC groundwater

  • Refinement of PEC values and extended modelling

• PBT and vPvB assessment

• Environmental risk assessment report (expert report)

• Dossier Module 1.6 of the human medical substance dossier, including verification of the environmental assessment