Regulatory Maintenance of Existing Marketing Authorizations within the Scope of Life-Cycle-Management

  • Processing of variations
  • Processing of renewals
  • Assistance in obtaining production scale validation data
  • Provision of long-term stability data on production batches (follow-up stability data)
  • Update of registration dossiers
  • Revision of obligatory texts
  • Preparing of Periodic Safety Update Reports (PSURs)
  • Line extension (e. g. for new indications or dosage forms)
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