With our expertise in the linguistic aspects of European regulatory submissions, your product, and reputation, are in safe hands.
We work exclusively with language experts from the life sciences field, and can walk you through the translation requirements of your submission.
Dora Wirth (Languages) Ltd. has extensive experience in the translation of Product Information required by the EMA for their procedures for MAAs and Variations.
DWL is involved in the translation process for MAAs on a daily basis and therefore covers all relevant aspects of the different procedures.
This includes non-EU Marketing Authorisation Applications involving the translation of parts of the Common Technical Document (CTD) or similar types of documentation.
With the increasing amount of regulation in both traditional and emerging markets, DWL’s service also includes translation of regulations into English from the target market language, as well as documentation for submission into the target market language.