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Regulatory eCTD Publishing


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Australia_New Zealand_eCTD

Regulatory eCTD Publishing

Regulatory eCTD Publishing operates in the healthcare sector within Australia and New Zealand, primarily within the pharmaceutical industry, and offers visionary cost-effective solutions to electronic document management, including distribution of eCTD Office software, training and provision of submission management services.
We provide expertise in regulatory strategy, training and preparing your submissions in NeeS and eCTD format. 
We can help you improve efficiencies in the submission preparation process, saving time and resources by providing

• eCTD Office software, as a distributor with support services 
• Customised training in software and electronic submissions management 
  • Electronic publishing to generate TGA- and Medsafe-compliant navigable dossiers 
  • NeeS structure 
  • Submission-ready documents 
  • Fully bookmarked and hyperlinked CTD and Module TOCs 
  • Integrated Word PI and CMI documents 

We can help you increase efficiencies of local archive processes by implementing a paperless regulatory environment.
Ease of navigation within high quality electronic dossiers is crucial for effective evaluation by health authorities