Regulatory Expertise

Regulatory Expertise

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.

Consolidation is widespread in the translation industry, and to improve market position many LSPs are merging, turning to technological solutions or shifting their focus to multiple verticals.

But at Dora Wirth (Languages) Limited, we are strengthening our commitment to support the life sciences by focusing on our core specialism: European regulatory submissions and market access.

We combine excellence in project management, in-house medical experience and a global supply chain of linguists who are recruited and evaluated according to our Quality Management System (QMS).

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.