Regulatory Affairs / Translation Solutions

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:

  • Centralised Procedure (CP)
  • Type IA/IB and Type II Variations
  • Mutual Recognition Procedure (MRP)
  • Decentralised Procedure (DCP)
  • Referral Procedure

 

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:

  • First drafts
  • Rapporteur changes
  • CHMP opinion changes
  • Linguistic reviews by the National Competent Authorities
  • Bookmarking of pdf conversions

 

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:

  • Regulations into English from the target market language
  • Documentation for submission into the target market language

 

Contact us to discuss your submission and timelines.

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