Submission Publishing

As a fully licensed regulatory publisher of electronic dossiers, we frequently prepare submissions intended for  regulatory agencies across Australia, Europe and North America. Recognising the recent industry shift to the electronic dossier format of the Common Technical Document (eCTD), we provide a full publishing service for eCTD using Lorenz publishing software. Each eCTD sequence is reviewed, quality controlled, and validated to ensure a streamlined submission process for regulators. All documentation is prepared in accordance with ICH Common Technical Document (CTD) for medicine application and following the IMDRF Technical File formats, ensuring the application structure reflects not only best practice, but importantly modern regulatory standards.