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
- Simplify and standardize the entire regulatory publishing process
- Dramatically improve efficiency
- Reduce time to market
- Repurpose your information assets time and again
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
- 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
- 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
- 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)
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