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Our regulatory affairs professionals continually monitor the requirements for electronic submissions in order to ensure that the most recent agency guidance documents and specifications are followed. To support our global capabilities in regulatory submissions, we have implemented CoreDossier®. This electronic publishing tool allows for the timely and efficient preparation and publication of regulatory submissions whether in paper or electronic form.
We have considerable experience in the preparation, publication and submission of applications in Common Technical Document (CTD) format. To date, we have prepared and submitted more than 10 full applications in CTD format and, in addition, have prepared more than 50 individual CTD documents. CoreDossier® enhances our services in this area as well as providing complete eCTD capability for both the United States and the EU.
CoreDossier® is a registered trademark of Liquent Inc.
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