Human Health Sciences
Assessment of the potential effects of chemical substances on human health is a key part of a regulatory submission.
TSGE’s Human Health Sciences team ensures regulatory data requirements are met by assessing exposure levels, setting endpoints and performing risk modelling for product application submissions.
Our team brings together specialists in exposure modelling, risk assessment and toxicology, who have a wealth of expertise in data interpretation, hazard assessment and characterisation of substances gained from previous experience in industry, research facilities and government organisations.
Our toxicology specialists have successfully represented clients at meetings of the ECHA Risk Assessment Committee, applied read-across and data waiving approaches to reduce animal testing and associated costs for REACH registration dossiers, and presented successful arguments in favour of applying less conservative mammalian endpoints for the risk assessment of plant protection products.
Our exposure specialists have broad experience in conducting screening and higher tier assessments for occupational, consumer and secondary exposure scenarios using standard models and have designed non-standard models for estimating human exposure to biocidal and household products.
TSGE has experience in meeting regulatory data requirements and in minimising toxicological testing through the use of alternative approaches such as QSAR, read-across and data waiving.
Should you wish to discuss any of our services, please contact us.
- Advice on data requirements
- Data gap analysis
- Advice on testing strategy
- Study monitoring including study placement and protocol review
- Dossier preparation
- Cosmetic Safety Assessment
- Theoretical assessments of toxicokinetics
- Human exposure modelling
- Development of bespoke exposure models
- Human risk assessment
- Chemical Safety Reports (REACH)
- Advice & support on Classification & Labelling
- Representation at National Authorities, European Commission, ECHA