The backbone of the company and the key to our success is our scientific expertise bundled in the Regulatory Science Business Unit. Experts from all regulatory relevant disciplines, such as chemists, physicists, food chemists, biologists, geo-ecologists, toxicologists, ecotoxicologists, environmental fate specialists and agronomists are united under one roof. This access to a wide spectrum of expert knowledge ensures that our clients can take advantage of a very competent and highly efficient service.

Based on detailed analysis of your database and the resulting data gap analysis, we design, contract and scientifically monitor all studies necessary for the dossier. We know exactly how the dossier needs to look like, how to perform state-of-the-art risk assessments, as well as knowing which studies and expert statements have to be included where. We have frequently demonstrated successful dossier submissions and defence of compounds with our expert work.

The experience and detailed knowledge of the Regulatory Science Business Unit means that we provide our clients with experienced, professional service to assist in obtaining registrations.

 

Study monitoring in physico-chemical properties, analytical methods, toxicology, residues, environmental fate and ecotoxicology

We design and contract all the necessary studies at the laboratories best suited to meet your specific needs if you do not have in-house capacity. We cooperate with either contract or your in-house laboratories through the testing and reporting phases (monitoring) in order to guarantee full compliance with regulatory and scientific requirements and standards. We have massive experience in designing, monitoring and evaluating higher tier studies (e.g. operator exposure studies (OPEX studies), micro-/mesocosm studies, birds/mammals (e.g. focal species and effect studies) as well as NTA/bee semi-field and field studies).

Study monitoring is usually part of a registration process; however, it can also be done as a stand-alone project.

 

Regulation (EC) No 396/2005 of the European Parliament and of the Council describes the basic rules for the setting of Maximum Residue Levels (MRLs) of pesticides in products of plant and animal origin, harmonised for all Member States of the EU. We are assisting several companies in generating numerous application dossiers and forms. We have direct contacts to the authorities and can take care of MRL applications for crops traded within the EU. Furthermore, we take care of the MRL setting for imported products to meet the level of international trade (i.e. import tolerance applications) as well as the setting of world-wide MRLs (i.e. Codex Alimentarius MRLs).

 

Environmental fate and modelling/Human and ecotoxicological risk assessments

Simulation models are a very useful tool for assessing and estimating the environmental, ecotoxicological and human health risk of pesticides, chemicals and biocides.

For environmental exposure assessments, we use a number of models including those which are recognised from the FOCUS group (Forum for the coordination of pesticide fate models and their use). The use of these models enables us to characterise substance properties that are relevant to their environmental fate and estimate the predicted environmental concentration (PEC) in soil, groundwater, surface water and air. The PEC values calculated are used by us to perform ecotoxicological risk assessments based on characterisation of exposure and effects.
Higher tier studies can be employed in order to solve critical assessments.

We perform ecotoxicological risk assessments according to current guidance documents and regulations and also take into consideration recent developments in the regulatory framework of the European Union and the rest of the world. The development of strategies for environmental risk assessments based on the results of higher tier studies on community level or under complex exposure conditions becomes more and more important and is also part of our teams concerning environmental fate and ecotoxicological aspects.

For human risk assessment, we use all current exposure models for the prediction of acute and chronic consumer exposure (e.g. EFSA model, WHO models, various national models) as well as operator, worker, bystander and resident exposure. Available background or supporting data are taken into consideration on a case-by-case basis in order to refine the risk assessment (including probabilistic approaches).

Environmental risk assessment (ERA) and pre-clinical study monitoring

We provide scientific services to suit the needs of the pharmaceutical industry. The guideline on the environmental risk assessment of medicinal products for human use (adopted on 01.06.2006), refers to the guidelines and test protocols issued by the European Commission, OECD and ISO. Based on the extensive experience which our experts have gained in the difficult field of agrochemicals with environmental risk assessments (fate, exposure, effects, risks), we can offer you full scientific and regulatory service.

We are well-versed in study monitoring, i.e. planning and monitoring studies such as:

  • Pre-clinical studies on mammalian toxicology.
  • Studies on the environmental fate and behaviour.
  • Studies on effects to aquatic and terrestrial organisms.

We can prepare expert statements regarding questions on mammalian toxicology, ecotoxicology as well as environmental fate and behaviour. Environmental risk assessments and comparing potential exposure with potential effects are an integral part of our services.