Translation to various languages worldwide thanks to carefully selected partners
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)
Tracked changes and comments while proof reading a Maltese translation for one of our clients
