The generation of data for regulatory compliance is often based on experimental work and can be complex, time consuming and costly. These studies provide much of the data presented to regulators and form the basis for regulatory approval of substances and/or products. With so much at stake, it is important that such studies are completed to the highest standards whilst using the best technical approaches to maximise the chances of good data generation.
At CEA, our study monitoring team has many years of experience designing and overseeing experimental studies for regulatory data generation and dossier building (e.g. Physical Chemical, Toxicology, Ecotoxicology and Environmental Fate and Behaviour).
From finding the right lab for your needs to optimising a study plan, CEA can be your expert guide every step of the way. CEA has good working relationships with a number of test laboratories, and can place big and small orders – from individual studies addressing specific endpoints or data gaps to full regulatory packages such as REACH Annexes VII or VIII.
Employing an independent, informed expert for study monitoring also allows for open scientific dialogue throughout, and on interim and results prior to the final report. In addition, it reduces the potential for bias in any conclusions which may be drawn.
Discover more about study monitoring in our detailed brochure.