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Regulatory support

We prepare dossier sections for plant protection products for the EU, with a particular focus on ecotoxicology, environmental fate and toxicology

Dossier preparation, data gap analyses and more

We prepare complete dossier sections for active substances and plant protection products for EU, zonal and national submissions according to (EC) No 1107/2009 and current guidance documents. Prior to dossier preparation we offer to conduct data gap analyses and preliminary risk assessments. Following dossier submission, we support you in answering requests by authorities. While we focus on the areas ecotoxicology, environmental fate and toxicology, we prepare full dossiers in cooperation with our partners.

Our service for dossier preparation includes:

  • Data gap analysis
  • Preliminary risk assessment
  • Standard and higher tier risk assessments
  • Preparation of report summaries
  • Completeness check
  • Expert statements
  • Answering requests of authorities

Related links

Ecotoxicological risk assessments

Ecotoxicology

For the registration of active substances and plant protection product our experienced team prepares dossier sections and risk assessments.

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Environmental Fate

Prior to dossier preparation we offer to conduct data gap analyses and preliminary exposure assessments.

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Effect modelling

Effect modelling & population modelling

We use effect modelling, GUTS, TKTD or population modelling as an important toolset of ecotoxicological risk assessments.

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