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Regulatory Affairs

Dora Wirth (Languages) Limited

Translation of Product Information into 23 languages for Centralised Procedure & Translation of Type IA/IB and Type II Variations.

Translation of Marketing Authorisation Applications (MAAs) (the complete Product Information and/or Variations) into 23 languages for the EU (including Norwegian and Icelandic). QRD-compliant translations within the requested timelines for Centralised Procedures.

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