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)
- Languages covered for translations include Maltese, French, Russian, Ukrainian, Belarusian, Kazakh and Moldovan
OTHER SERVICES:
