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IASON consulting assesses ecotoxicity data generated in studies following Good Laboratory Practices (GLPs) and internationally standardized guidelines provided by the Organisation for Economic Co-operation and Development (OECD) as a part of new marketing authorization applications (MAA) for medicinal products and type II variations or line extensions.
Directive 2001/83/EC states the necessity of EMAs for new marketing authorization applications (MAA) of medicinal products or variations thereof.
The main objective of ERAs is to systematically investigate chemicals applied within drugs and medicinal use and chemicals which are intended for respective application. In this connection, the focus of ERAs lies within the analysis of applied chemicals and chemicals intended for use and if they can be processed as intended, without causing adverse effects to human health or the environment.
IASON consulting has been offering full-service marketing authorization support within the health science industry since 2004. Our one-stop-shopping services include guidance, review, scientific support, and the compilation of full or partial medicinal product applications, reviews, and reports for national and international approval of respective authorities such as EMA and FDA, as well as in-house use.
We gladly advise you with regard to the necessity, preparation, and execution of your specific ERA according to guidelines as, for example, provided by the OECD (Organisation for Economic Co-operation and Development).
Please, do not hesitate to contact us with a specific request, or if you just want to learn more about services throughout the health science industry provided by IASON consulting.