• Preparation of dossiers for (national) submission of marketing-authorisation applications (MAA), including PIL readability tests, PIL and SPC writing, translations, Non-Clinical and Clinical overviews, Quality Overall Summary, etc.;
  • Process follow-up / contacts with Authority;
    Note: we can act as Marketing Authorisation applicant on behalf of the Client.
  • Dossiers maintenance / update, format conversion;
  • Variations;
  • Translation of technical documents to/from Portuguese from/to other languages;