Dossier preparation and regulatory support
We prepare ecotoxicology 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. Our services for dossier preparation include:
- Data gap analysis
- Preliminary risk assessment
- Standard and higher tier risk assessments
- Preparation of report summaries
- Completeness check
- Expert statements
- Answering requests of authorities
Standard and higher tier risk assessments
We conduct standard and higher tier risk assessments based on current guidance and ecological and ecotoxicological expertise.
Effect modelling & population modelling
We use effect modelling, GUTS, TKTD or population modelling as an important toolset of ecotoxicological risk assessments.
Low variability and uncertainty honeybee trials (GLP)
In order to meet protection goals defined by EFSA low variability and low uncertainty honeybee field or semi-field trials are needed.