Submission Publishing

Digital Services

Overview

The number of clinical documents required by regulatory agencies has increased dramatically with new drug safety guidelines. 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 Overview, and CCDS 


The 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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