How can our team support you?
Data gap analysis and intelligent testing strategies:
Having worked on a considerable number of new plant protection product active substance authorisations and active substance renewals our team is well placed to understand the regulatory needs and requirements to attain successful submissions in a cost effective and timely manner. For chemicals we have worked on hundreds of lead and joint registrations with associated chemical safety assessments.
Every member in the team has come from a Contract Research Organisation background and have first hand experience of conducting biodegradation and environmental fate studies. This technical experience is invaluable in making sure our Clients studies are monitored and conducted to a very high standard. We have numerous relationships with Contract Research Organisations all over the world for coordinating and conducting studies on behalf of our Clients.
Further support comes in the interpretation of the study results and derivation of endpoints for use in the regulatory submission. For plant protection products tools such as CAKE can be used for the evaluation of degradation kinetics in new or legacy soil and sediment water studies in accordance with FOCUS kinetic guidance.
We have conducted numerous modelling assessments in support of new active substance submissions (representative uses), product renewals and label extensions. All of our modelling reports come in a user-friendly dRR format for easy inclusion into product dossiers.
FOCUS GW modelling
FOCUS SW modelling (STEP 1-4)
Environmental modelling for National submissions:
We have extensive knowledge of the National requirements and mitigation options required for each country in the EU and can provide support with the following tools:
UK – Drainflow calculator and MACRO 4.3
DE – EVA and EXPOSIT
NL – TOXSWA-NL and GeoPEARL
Higher tier modelling / exposure refinements:
We understand the difficulties and problems that can arise when conducting risk assessments. We are to provide advice and support to refine exposure values with the following modelling tools:
VFSmod – refinement of vegetative filter strips
GEM – for refining greenhouse specific scenarios
EPAT – to investigate the exposure emission pattern over time
We are able to prepare the relevant environmental fate sections for dossiers and support in the completion of other relevant supplementary sections: Environmental Fate active substance dossiers (MCA and MCP Sections 7 and 9)
Environmental Fate product dossiers (dRR Part A and dRR Part B Section 8)