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Our Services within the Environmental Risk Assesment on Human Pharmaceuticals

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:

  • 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

Guiding you safely...

You have specific questions or wish to get to know more about our services?

Let us know how we can support you.

Ana Šulc

Senior Regulatory Scientific Expert at Vali is looking forward to receiving your email.

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