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- 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;
- Translation of technical documents to/from Portuguese from/to other languages;