Scientific Regulatory Services
With the regulatory environment getting increasingly stringent across the globe, expert knowledge takes the crucial role in the market success in general, and gaining approval for substances and products of our customers specifically. We rely on our long-lasting scientific expertise bundled in the Regulatory Science business unit to offer professional registration services to our customers.
On your behalf, we design and contract all necessary studies at the research institutions fitting best to your needs or cooperate with your in-house laboratories.
Study Monitoring Overview
We offer study monitoring for physico-chemistry, analytical methods, toxicology, residues, environmental fate and ecotoxicology, including higher-tier studies.
Modelling and Risk Assessment
We have an established expertise in exposure modelling and risk assessments both in the sphere of ecotoxicology and human health. We perform eco- and toxicological risk assessments in line with current guidance documents and regulations and by taking into account recent regulatory developments.
Modelling and Risk Assessment Overview
Our experts are highly experienced in the efficient use of simulation models needed for environmental and human health risk assessment.
We support our clients with expert work and judgment regarding ED properties of compounds to confidentially guide them through the difficulties in developing target-specific strategies.
Endocrine Disruption Overview
We have in-depth expertise in the evaluation of specific toxicity endpoints and apply state-of-the-art models and databases to develop an appropriate assessment strategy.
Our expert team of computational chemists, biologists, toxicologists and regulatory specialists support you in evaluating and predicting the (eco)toxicity of your compounds and help you with assembling the lines of evidence.
In Silico Overview
We routinely generate in silico data and perform knowledge- and statistically-based QSAR models.
Maximum Residue Levels (MRL) and Import Tolerances (IT)
We have hands-on knowledge of European and international registration processes and profound regulatory and scientific expertise in all disciplines relevant for MRL setting (analytics, toxicology, residues).
MRL/IT Services Overview
We are experienced in handling all kinds of MRL applications, including setting of EU import tolerances as well as Codex MRLs.
Product performance as well as efficacy testing and assessment are far more than mere regulatory requirements of the registration process. Much more, they can guarantee the effectiveness, safety and economic benefits of your product, becoming a quality mark, an asset in the product value chain.
Our efficacy experts provide you with comprehensive expertise in product performance and efficacy testing and assessment.
Classification and Labelling (CLP)
Based on our profound expertise in regulatory (eco)toxicology, our experts ensure your compliance with the classification and labelling requirements.
We have hand-on experience in preparation of CLH dossiers and support you with C&L inventory and PCN notifications.