• 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.

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• Submission formats:

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