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Software > Assembly & Publishing > CoreDossier®: Features & Benefits |
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CoreDossier®: Features & Benefits
Overview > Features & Benefits > Technical
Specification
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
Output
- Features high-speed printer compatibility that includes automatic insertion of tabs, slip sheets and cover pages on printed versions
- Offers a wide range of output channels: PDF, paper, standard PostScript, Docutech PostScript, eCTD, CDER and CBER
Automated Paper and Electronic Compliance
- Provides audit trail capabilities to support 21 CFR Part 11 compliance on a per publication basis
- Provides automatic finishing options: table of contents generation, cross-references, headers, footers, watermarks and pagination schemes
- Automatic file and folder naming so there is no risk of misspelling file and folder names
- Automatic volume creation that complies with file or page-count requirements
- More than 10 submission templates for quick and easy assembly including CTD/eCTD templates
- Ability to create your own submission templates.
Author and Publisher-Bases Hyperlinking and Cross-Referencing
- Enables publishers to create links by automatically embedding cross-references throughout the entire submission
eCTD Creation
Benefits
- 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
- Is scalable to meet the needs of a growing organization
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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