Submission Publishing

Digital Services

Overview

The number of clinical documents required by regulatory agencies has increased dramatically with new drug safety guidelines. Atos|Syntel's publishing team is made up of doctors, life science experts, and technology experts ready to translate your complex data and results into formatted, regulatory-compliant documents.

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Offerings

  • Document and module-level publishing
  • eCTD compilation and submission for IND, NDA, ANDA, CTA, MAA, DMF, SPL and others
  • Submissions in electronic (eCTD, NeeS) and paper formats to FDA EU and other regulatory agencies
  • Dossier writing for clinical study reports (Ph I-III), safety aggregate reports (PBRER-PSUR, PADER,DSUR), summary documents, clinical overviews, and CCDS 

 

The Atos|Syntel Advantage

 
  • Document, report and submission-level publishing management
  • Expertise in electronic submission standards, regulatory guidelines and compliance 
  • Intelligent process automation with the SyntBots® automation platform
  • Operational cost optimization to manage peaks and valleys in your submission schedule

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