Study Monitoring
Do you have a new substance that needs to be registered according to Regulation (EC) No. 1907/2006 (REACH) or do you need a confirmation of shelf life of a substance or or a product according to Regulation (EC) No. 528/2012 (BPR)? Are you required to conduct studies according to GLP, OECD or ISO guidelines? Testing and the monitoring of studies can be challenging in terms of time, requirements and correspondence with the chosen Contracted Research Organisation (CRO).
Our company provides specialized consulting services in the field of (eco)toxicology, environmental fate, and efficacy testing. With extensive experience in study monitoring, we ensure that all contracted research is designed, conducted, and documented in full compliance with requirements of the relevant regulatory frameworks.
We coordinate and oversee studies performed by Contract Research Organisations (CROs), ensuring clear communication, scientific accuracy, and adherence to agreed timelines. Our expertise extends to the critical evaluation of study results and the development of data-driven strategies to address identified regulatory data gaps.
Through a combination of scientific competence and regulatory insight, we support our clients in achieving reliable and robust datasets that facilitate efficient dossier preparation and successful regulatory submissions.