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European Medicines Agency (EMA) Marketing Authorisation Applications (MAAs) and Variations using QRD (Quality Review Documents) Word templates for both human and veterinary medicinal products.
DWL 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 such as:
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 involves both the translation of:
Contact us to discuss your submission and timelines.