Product/Service

Liquent CoreDossier™

Source: Liquent, Inc.

There's a reason why 33 of the top 50 pharmaceutical companies -- and life sciences organizations of all sizes -- use CoreDossier as their submission publishing solution.
Over 5,000 successful submissions. And counting...

There's a reason why 33 of the top 50 pharmaceutical companies (and life sciences organizations of all sizes) use CoreDossier as their submission publishing solution. In fact, there are many reasons:

  • It automates the entire regulatory publishing process
  • It is the only solution that transforms up to 155 file formats to PDF while maintaining 100% page fidelity
  • It is the only solution that integrates with multiple repositories simultaneously
  • It can be implemented on one server, or multiple servers depending on need and scalability requirements
  • It supports multiple simultaneous output formats (e.g., PDF, paper, CD-ROM, Web, etc.)
  • It has successfully published over 5,000 submissions, including some of the largest submissions in the world
  • It is backed by a company with over a century of combined regulatory expertise and a services organization that helps you get the most out of your solution
The fact is, your submission publishing process is absolutely mission critical. Your job depends on it. Your company's success depends on it. So why not depend on the one company that has proven its ability to deliver solutions that help you:
  • Simplify and standardize the entire regulatory publishing process
  • Dramatically improve efficiency
  • Reduce time to market
  • Repurpose your information assets time and again
Features & Benefits

When preparing a submission, your success depends on:

  • Managing your critical information
  • Accessing and compiling source documents
  • Reviewing and publishing the dossier
  • Complying with continually changing regulatory requirements
CoreDossier offers a complete, fully scalable solution that:
  • Can be used alone or in conjunction with your document management system
  • Supports over 150 native file formats
  • Offers a wide range of output channels: HTML, PDF, TIFF, CD-ROM, Portal, paper, standard PostScript, Docutech PostScript, CDER and CBER
  • Provides audit trail capabilities to support 21 CFR Part 11 compliance on a per publication basis
  • Enables the assembly of smaller publications that feed into larger submissions
  • Provides automatic finishing options: table of contents generation, cross-references, headers, footers, watermarks and pagination schemes
As a result, you reap the following benefits:
  • Highly automated compilation of compliant electronic and paper output
  • Simultaneous submission to multiple regulatory agencies
  • Assured currency with the latest regulatory guidances
  • Improved time to market
  • Reports and submission components that can be easily leveraged for future needs
CoreDossier easily handles the complex job of creating regulatory dossiers and is used by companies the world over to produce:
  • Investigational New Drug Applications (IND)
  • electronic Investigational New Drug Applications (eIND)
  • New Drug Applications (NDA)
  • Abbreviated New Drug Applications (ANDA)
  • Common Technical Documents (CTD)
  • electronic Common Technical Documents (eCTD)
  • 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)
Repository neutral. Proven technology. Regulatory expertise. No other publishing solution provides you with the features and benefits you need when your mission-critical submission is on the line.