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Maintenance

  • Variations 

  • Renewals

  • Follow-up-activities

  • Dossier management and revisions

  • Dossier reformatting: NTA - CTD -  eCTD

  • Product Information Update (SmPC, PIL, labeling)

  • Preparation of Periodic Safety Update Reports (PSUR)

  • Preparation of pharmacological and toxicological expert reports, clinical expert reports, environmental compatibility testing, etc.

  • Submission formats:

  - eCTD - electronic Common Technical Document
  - vNeeS - veterinary NeeS

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