Submission Preparation and Management
  • Dossier project management of MAAs and major variations

  • Publishing of legacy files from paper or scanned image to eCTD ready documents

  • Compilation and maintenance of eCTDs, non-eCTD electronic submissions (NEESs) and ASEAN-CTDs

  • Hosting of eCTDs and NEESs

  • Burning CDs/DVDs, printing of labels and coordination of dispatch of CDs/DVDs and/or paper copies

  • Preparation of PostScript files for printed output, allowing printing anywhere in the world

  • Assembly and dispatch of electronic and paper dossiers

  • Compilation, lifecycle management and regulatory status tracking

  • Coordination with Regulatory Agencies on technical issues related to eCTD submissions

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