A complete and reliable data package is a prerequisite for the successful registration of active substances and products. Where higher tier is needed, the right strategy is crucial. Literature research? Expert statement? Back to lab? Tailor-made field study? New data evaluations? Modelling? A combination? Beginning from a solid data gap analysis and preliminary risk assessment approaches, we guide you through the options and develop the best possible way forward.
Ecotoxicology is represented at RIFCON by several teams with high headcounts, and close connected to all field study department teams. With regard to the extent, it is a unique feature of our CRO & consultancy.
Working closely with field experts, our ecotox experts design our customised field studies or evaluate best options with effect modelling and statistics experts for individual study designs or modified standard studies.
Where appropriate, higher risk assessments based on lab and field data can be complemented by TK/TD and population models for a better overall picture of potential risks. Thus, we can guarantee a most solid and consistent data package following higher tier options, both available and commonly applied or developed in accordance with latest data requirements and our ideas for your registration.
Furthermore, we regularly host workshops covering different aspects of environmental risk assessment. The workshops are certified within the SETAC Certification of Environmental Risk Assessors Programme
We are here to help!
Find out how we can support you assessing the environmental fate of your substance
What can we do for you?
Strategy-Making
- on EU- Zonal- or member state level and globally
- planning, monitoring, and evaluation of all tier lab and field studies
- for all common and particularly specific application types
Endocrine Disrupting Properties
- precise analyses of potential endocrine effects
- regulations (EU) 528/2012 and (EU) 1107/2009
Dossier
- preparation of dossier sections for MCA/MCP and dRRs
- authority requests
- expert statements
- recalculations of endpoints
- QSAR analyses
- literature reviews
Study Monitoring
- wide network of experienced laboratories
- quotation gathering
- staying close to the study progress
- check of study designs and reports
- notification
Data Analysis
- impact analysis of new guidance documents (e.g. birds and mammals, pollinators): be prepared for new guidance!
- data gap analysis
- check of complicance with regulatory requirements
- preliminary assessment and recommendations for refinement, incl. cost estimation
SETAC-certified Workshops
- client-specific
- public
- for authorities
- ask for customised workshops for your specific requirements
