Thomson Reuters
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Liquent CoreDossier®


 

Electronic regulatory publishing made simple

Liquent CoreDossier is a proven, industry-tested software solution that meets all of your regulatory publishing needs. Backed by an organization with renowned regulatory expertise and a services group that helps you get the most out of your solution, CoreDossier is the chosen tool for small, mid-size pharma, biotechs, CROs, and global, multi-site organizations who are all required to create compliant electronic and paper submissions.



FEATURES

  • Robust Publishing solution that enables the reuse of information throughout the product development lifecycle
  • Eases assembly with simple drag-and-drop features, making it easy to rearrange or customize your submissions
  • Can be used with the file system or in conjunction with your document management system
  • Incorporates external created and scanned documents
  • Supports over 100 native file formats
  • Enables the assembly of smaller publications that feed into larger submissions
  • Simplifies the tracking of multiple submissions by providing one place to see every publication in your pipeline

BENEFITS

CoreDossier improves the efficiency of the entire regulatory publishing process, and streamlines the reuse of information:

  • Automate the whole regulatory publishing process, with highly automated compilation of compliant electronic and paper output
  • Simultaneous submission to multiple regulatory agencies with ease
  • Assured currency with the latest regulatory guidance’s
  • Improved time to market
  • Reports and submission components that can be easily leveraged for future needs
  • Scalable to meet the needs of a growing organization.



 


 

Additional information

CoreDossier easily handles the complex job of creating regulatory dossiers and is used by companies the world over to produce:

Electronic Common Technical Document (eCTD)
Common Technical Document (CTD)
Investigational New Drug Applications (IND)
electronic Investigational New Drug Applications (eIND)
New Drug Applications (NDA)
Abbreviated New Drug Applications (ANDA)
Biologics Licensing Applications (BLA)
Non-Clinical, Clinical and Human Pharmacokinetics Bioavailability Reports
Investigational Device Exemptions (IDE)
510K and Pre-Market Approval (PMA) for Medical Devices
Marketing Authorization Applications (MAA)
New Drug Submissions (NDS)
Clinical Trial Applications (CTA)
Clinical Trial Exemptions (CTX)

 
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