Services

Electronic submission of your Common Technical Document can reduce time to approval and provide substantial cost savings on printing, shipping and resource time. The eCTD enables easy navigation around your dossier and provides lifecycle management of your submission when updating and supplementing information.
Regulatory agencies that accept the eCTD format require standard technical specifications, including PDF format for component documentation linked together using an XML “backbone” for navigation. Accovion’s Medical Writing and Electronic Publishing team has the tools and know-how to apply the eCTD specifications. You’ll receive advice from the earliest stages in the development of your CTD modules to ensure that your dossiers are compliant.
Damien Lynch, PhD
Director, Medical Writing and Electronic Publishing
+49 6196 7709-301