Our scientific skills
Highly qualified employees
Our scientists and project managers are highly skilled in various scientific and regulatory disciplines. Based in many countries, they offer extensive expertise, language skills and strong relationships with many regulatory authorities.
For reliable and robust data
Our scientists ensure that all required analytical methods have been properly developed and validated. The objective is to guarantee precise measurements for each active substance, both in the product (after storage), and in other matrices in order to determine the residue levels in plants, air, water and soil.
Thus, the analytical methods we use in our studies are robust, reliable, and provide accurate results.
Our main aims for biological and chemical substances or products
- Identifying which data is already available, which need to be generated and whether unprotected data or a scientific justification or waiver can be used, rather than undertaking a new study.
- Arranging & monitoring the development and validation of analytical methods (GLP) to detect residue levels of the active substance in the formulated product, plant materials, soil, air, water, body fluids etc.
- Providing advice on non standard studies.
- Preparation of the relevant regulatory dossier sections.
All work is conducted in accordance with the relevant EU guidance documents, using approved formats.
Understand the level of exposure and risk to various organisms
Our experts in ecotoxicology have both a wide range of skills in laboratory and field work, and extensive experience in regulatory ecotoxicology. They closely follow developments in the risk assessment process by regularly participating in cutting-edge conferences and working groups on these subjects.
Our main aims for biological and chemical substances or products
- Identifying which data are already available, which need to be generated and whether unprotected data or a scientific justification or waiver can be used, rather than undertaking a new study.
- Arranging & monitoring the standard package of GLP ecotoxicology studies, required for the substance or product.
- Undertaking the risk assessment appropriate to the country or region, working closely with others across the team to propose solutions to our clients when refinements are needed.
- Developing higher-tier refinement options tailored to specific regulatory questions, using reasoned arguments and/or testing strategies.
- Preparation of the relevant regulatory dossier sections – assessing the risk to non target organisms.
- Preparation of ad-hoc technical documents for specific requirements.
The Ecotoxicology team works closely alongside the Environmental Fate team, using data on the environmental concentration in various compartments (e.g. surface water, soil), so that this can be used to understand the level of exposure of different organisms to the substance.
Data and the risk assessment undertaken by the Toxicology team is also used by the Ecotoxicology team to understand the potential toxicity of the substance and product to non-target organisms.
Double competence: agronomist and regulatory expert
Our Efficacy Team can provide support for products used to protect plants (agricultural and home garden use products) and also non-agricultural pesticides. Individuals within the team have practical hands-on experience in the field, for example as agronomists, combined with many years experience working in regulatory affairs.
We assist our clients in
- Identifying which data are already available, which need to be generated and whether unprotected data or a scientific justification or waiver can be used, rather than undertaking a new study.
- Development or validation of trial programmes – to assess the efficacy of products, selectivity, effectiveness, risk of resistance etc.
- Commissioning and study monitoring of efficacy studies (GEP for plant protection products)
- Undertaking the efficacy assessment appropriate to the sector, country or region, working closely with others across the team to propose solutions to our clients when refinements are needed.
- Dossier preparation.
- Scientific arguments / waivers.
- Preparation of ad-hoc technical documents for specific requirements
Protecting environment
Our experts assess the environmental fate and behavior of substances in the environment. They gather and model test and modeling data in order to estimate the levels of active substance that can reach the different compartments of the environment (soil, water, air). Different models are needed to simulate each possible situation. For example: climatic conditions and specific agronomic practices are taken into account in the models required for agrochemicals.
Our main missions
- Identify what data is already available and what needs to be generated. Before undertaking a new study, we first check whether unprotected data, a scientific justification, or an exemption can be used.
- Implementation and monitoring of environmental fate studies (GLP)
- Undertake modeling of the environmental fate according to the country or region considered. The models used make it possible to assess the risks for the various environmental compartments, i.e. surface and groundwater, air, soil and sediments.
- Preparation of the dossier.
- Preparation of scientific arguments / derogations.
Our skills in human risk assessment
Our experts use the generated toxicology data, as well as details on the use of the products, to assess the risk for operators, workers and bystanders linked to the spraying or handling of pesticides.
Our main missions
- Identifying which data are already available, which need to be generated and whether unprotected data or a scientific justification or waiver can be used, rather than undertaking a new study.
- Undertaking non-dietary exposure risk assessments using the relevant models to assess the risk operators, workers and bystanders from use of the products.
- Developing higher-tier refinement options tailored to specific regulatory questions, using reasoned arguments and/or testing strategies.
- Arranging & monitoring any specific GLP studies, required for refinements.
- Preparation of the relevant regulatory dossier sections.
- Preparation of ad-hoc technical documents for specific requirements.
Analyse to better understand
Our chemists analyse data on the characteristics of the active substance and/or product, whether chemical or biological, in order to better understand its physico-chemical properties.
Our main missions
- Identifying which data are already available, which need to be generated and whether unprotected data or a scientific justification or waiver can be used, rather than undertaking a new study.
- Characterisation of the substance; especially challenging for some biological substances.
- Understanding the manufacturing process and impurity profile (5 batch analysis), then proposing the technical specification. Preparing applications for technical equivalence.
- Arranging & monitoring the standard package of GLP physico-chemical studies to demonstrate the properties of the substance or product. Providing advice on non-standard studies and provision of bridging statements.
- Advice on classification and labelling, plus the creation or revision of Safety Data Sheets (SDSs).
- Ensuring that validated methods of analysis are available. When necessary, develop new methods.
- Preparation of the relevant regulatory dossier sections.
All work is conducted in accordance with the relevant guidance documents, using approved formats.
Data on the identity and physcio-chemical properties of the substance and formulation provides useful information for many other parts of the assessment, e.g. if the substance binds to fat (risk of bioaccumulation in certain organisms) or whether it volatilises (increased risk to air).
Assess all food-related risks
Our studies take into account the results of trials, the results of toxicological studies, and the specific diets of the countries concerned. The objective is to assess the risk of food on humans after acute or chronic exposure.
Pesticides used directly on food crops, but also those likely to contaminate spaces or surfaces on which food can be prepared or stored (e.g. livestock bedding or food preparation surfaces) are taken into consideration.
We assist our clients in
- Identifying which data is already available, which needs to be generated and whether unprotected data or a scientific justification or waiver can be used, rather than undertaking a new study.
- Arranging & monitoring the standard package of GLP residues studies, required for the substance or product.
- Undertaking the risk assessment appropriate to the country or region, working closely with others across the team to offer solutions to our clients when refinements are needed./
- Developing higher-tier refinement options tailored to specific regulatory questions, using reasoned arguments and/or testing strategies.
- Preparation of the relevant regulatory dossier sections – assessing the risk to non target organisms.
Assess human health hazards
Our toxicologists benefit from both practical laboratory experience and extensive regulatory expertise as consultants to industry. They closely follow developments in the hazard and risk assessment process by regularly participating in conferences and working groups at the forefront of these topics.
Our main missions
- Identifying which data are already available, which need to be generated and whether unprotected data or a scientific justification or waiver can be used, rather than undertaking a new study. Especially important to avoid the need for unnecessary vertebrate testing.
- Arranging & monitoring the standard package of GLP toxicology studies, required for the substance or product.
- Undertaking the risk assessment appropriate to the country or region, working closely with others across the team to propose solutions to our clients when refinements are needed.
- Developing higher-tier refinement options tailored to specific regulatory questions, using reasoned arguments and/or testing strategies.
- Preparation of the relevant regulatory dossier sections.
- Preparation of ad-hoc technical documents for specific requirements.
Toxicology data and the resulting risk assessment feeds into the operator/worker/bystander assessment, the consumer exposure assessment (residues in food) and the ecotoxicological assessment.
Regulatory services
Explore our other services
The combination of our expertise allows us to support our clients from start to finish to secure their product development.
Field services
Quality driven, we provide customised services for your agricultural research.
Laboratory services
Test, screen and evaluate efficiently thanks to our deep expertise and state-of-the-art equipment.
