Our Services for Regulatory Science

We offer you intelligent solutions for all your scientific and regulatory issues in physicochemistry, analytics, toxicology, residues, environmental fate and ecotoxicology. With us,  you have a highly competent team of committed experts well versed in the latest methods and standards.

Contact our experts

They can support you through every step of the regulatory process by addressing all kind of scientific questions and expertly guide your products to EU-wide and global success.

Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 298460).

Modelling and Risk Assessment

Simulation models are a very useful tool for assessing and estimating the environmental, ecotoxicological and human health risks of agrochemicals and biorationals, chemicals, biocides and medical devices.

Environmental Exposure and Ecotoxicological Risk Assessments

Environmental Exposure Assessments

While performing environmental exposure assessments, we use various models to characterise substance properties relevant to their environmental fate and estimate the predicted environmental concentration (PEC) in soil, groundwater, surface water and air. We apply the calculated PEC values to perform ecotoxicological risk assessments based on characterisation of exposure and effects. Among models we apply, there are those recognised by the FOCUS group (Forum for the coordination of pesticide fate models and their use) as well as the current models at national level.

The PEC calculations are conducted using a powerful server-based simulation environment together with efficient data extraction software, enabling us to investigate a huge number of combinations of substance properties, application timings, uses and scenarios.

Ecotoxicological Risk Assessments

We perform ecotoxicological risk assessments in line with current regulations and available guidance documents, while taking into consideration recent developments in the EU and global regulatory framework.

Based on the results of higher tier studies on community level or under complex exposure conditions, we develop strategies for environmental risk assessments which constitute part of our teams approach concerning environmental fate and ecotoxicological aspects.

Human Health Assessments

We have broad experience in the performance of human health exposure and risk assessments. For this purpose, we use all current exposure models for the prediction of acute and chronic consumer exposure (e.g. EFSA model, WHO models, TNsG (2007), BEAT, ConsExpo and various national models) as well as occupational assessments for operators, workers, bystanders and residents.

We examine available background or supporting data on a case-by-case basis to refine the risk assessment, including probabilistic approaches. We are well-versed in adapting standard models to non-standard uses.

The performance of human health exposure and risk assessments is usually part of dossier preparation. However, it can also be done as a stand-alone task.

Our Services:

• Environmental and human health exposure and risk assessments for all types of substances and products
• PBT assessment (persistence, bioaccumulation and toxicity)
• Tailored exposure and risk assessments for substances with non-standard applications, including endocrine active substances
• Study planning and monitoring of all kind of toxicological studies required in the context of environmental and human health exposure and risk assessments
• Derivation of the Environmental Quality Standards (EQS) and the German water hazard classes (Wassergefährdungsklassen, WGK)
• Weight of evidence (WoE) assessments: in vitro, in vivo and in silico data
• Predictive in silico toxicology assessments toxicology assessments
• Mode of action (MoA) analysis: adverse outcome pathway (AOP) concept.

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.

Environmental Assessments

We have experience in working with all relevant models to derive predicted environmental exposure values in different compartments.

Environmental Exposure Assessments

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.

These PEC calculations are conducted using a powerful server-based simulation environment together with efficient data extraction software, enabling us to investigate a huge number of combination of substance properties, application timings, uses and scenarios.

Ecotoxicological Risk 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 approach concerning environmental fate and ecotoxicological aspects.

Environmental Risk Assessment (ERA) for Pharmaceuticals

We have been conducting environmental risk assessments (ERA) for pharmaceuticals since the first version of the guideline on the environmental risk assessment of medicinal products for human use was adopted in 2006 (EMEA/CHMP/SWP/4447/00 corr 2). With this vast experience our team of biologists, pharmacists, (eco)toxicologists and chemists is well prepared for the challenges which might come with EMA's revision of the ERA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1).

Our Services

• Environmental risk and exposure assessments for all types of products and chemicals
• PBT assessment (persistence, bioaccumulation and toxicity)
• Tailored risk and exposure assessments for pharmaceuticals with specific classification, e.g. endocrine active substances and antibiotics
• Study planning and monitoring of all kind of studies required in the context of an environmental risk, exposure and/or PBT assessment (ecotoxicity, toxicology, fate and behaviour and physical chemistry)
• Derivation of the Environmental Quality Standards (EQS) and the German water hazard classes (Wassergefährdungsklassen, WGK).

Study Monitoring

Depending on your in-house capacity, we design and contract, if needed, all necessary studies at the laboratories best suited to meet your specific requirements, covering the following fields:

• Physico-chemistry
• Analytics
• Toxicology
• Residues
• Environmental fate
• Ecotoxicology
• Efficacy

We cooperate with either contract research organisations 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.

Our scientists have vast experience in designing, monitoring and evaluating higher tier studies, including:

• Operator exposure studies (OPEX studies)
• Field dissipation studies
• Groundwater monitoring studies
• Micro-/mesocosm studies
• Birds/mammals (e.g. focal species and effect) studies and
• NTA/bee semi-field and field studies.

Depending on your individual needs, our services for study monitoring can be both part of a registration process or a stand-alone project.

Please contact us to learn how we can help you with designing and monitoring your studies. 

Our task force/consortium experience is second to none. Over two decades, we have been involved in numerous task forces/consortia, ranging from two to well over dozens of member companies.

Conveniently located 45 minutes away from Frankfurt International Airport, we have meeting rooms available including modern electronic data presentation equipment and video conference facilities. We can also make similar arrangements for meeting room facilities and event management anywhere else in the world.

• Before and during the meeting:
  •  complete event management including travel arrangements and hotel accommodations
  • moderation / chairmanship
  •  scientific, regulatory and administrative competency.
• After meetings:
  •  preparation and distribution of meeting minutes
  •  reliable follow-up of action points.
• Between meetings:
  • communication between members / authorities / CROs
  •  organising and tracking of financial issues within the consortium/task force
    (We have at all times an actual overview of budget through our unique Cost and Project Information Database System (SCC-PRO))
  •  LOA cost calculations and follow up including LOA management
  • central archiving and database function to keep track of all pertinent documentation using the Electronic Document and Dossier Management System (SCC-EDDMS).

We offer complete task force/consortium management.