Dossier preparation and regulatory support
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 exposure assessments. Following dossier submission, we support you in answering requests by authorities. Our services for dossier preparation include:
- Data gap analysis
- Preliminary exposure assessment
- Standard and higher tier exposure assessments, including GIS analyses
- Preparation of report summaries
- Completeness check
- Expert statements
- Answering requests of authorities
Landscape-level analyses with GIS software and probabilistic approaches increase the realism of exposure assessments.
Exposure profile analyses
Linking aquatic exposure and effect assessment provides more realistic endpoints for the aquatic risk assessment.
We conduct kinetic analyses of laboratory or field dissipation studies to establish endpoints for the exposure and risk assessment.
We conduct PEC calculations with EU-agreed FOCUS models and national exposure models to ensure a safe use of products.