Proofreading of Maltese Translations

Proof reading Maltese translations, Pharmaceuticals, Service provider, Outsourcing, CRO, Malta, SPC, PIL, Labelling text, Annexes, EMA, Variations, Linguistic review, Quality check, Editorial changes, Editing, Tracked changes, Comments, Communication with Medicines Authority, Reliable, Meets deadlines
Tracked changes and comments while proof reading a Maltese translation for one of our clients

We are providing the following translation services:

  • Supporting the Linguistic review process of updated Product Information (Summary of Product Characteristics [SPC], Patient Information Leaflet [PIL] and labelling) and Annexes during EMA variation procedures
  • Translation services in order to implement the text changes from English to Maltese or Maltese to English of Product Information for D+5 submission
  • Proofreading of translated documents (English to Maltese or Maltese to English) to identify any spelling mistakes or typos throughout the text, tables and graphs
  • Performing Local Regulatory Affairs (LRA) and quality checks of translations
  • Checking of translated document compliance to QRD template, formatting checks, ensuring consistency of updated paragraphs with the rest of PI
  • Alignment of translated texts containing the same active ingredient
  • Implementing necessary editorial changes
  • Performing review of member state translation comments, communicating with member state reviewer and implementing necessary updates before submitting finalised texts (D+25 submission)