Reducing the expense of managing compliant electronic submissions
The effective management of validated and compliant submissions is a complex process. The need to build, view, validate and publish submissions based on standardized submission formats comes with its own set of challenges. In addition, managing submissions in multiple regions also requires that all submissions must be compliant with the ICH and regional specifications, which further complicates the overall process.
To ensure compliance, you need a solution that enables you to maintain a comprehensive overview of your submission statuses across a number of products within multiple different geographic markets. EXTEDO eCTDmanager is designed to meet exactly these needs and ensure effortless compliance with regulatory requirements.
- Rapid compliance with latest regulatory changes worldwide
- Ability to validate and publish submissions from a single application
- Improves submission quality and consistency
- Supports publication of submissions in structures and formats for all regions of the world
- Prepared for future standards like eCTD 4.0
- Supports parallel work locally and worldwide
- Sophisticated management of hyperlinks and bookmarks
- Conforms to ICH and regional filenames and 21 CFR Part 11
- Minimal hardware requirements, rapid deployment and system validation, high performance and minimum training
The comprehensive electronic submission management solution
eCTDmanager provides you with a complete regulatory dossier assembly and management solution. Its scalable, all-in-one submission management capabilities meet the requirements for both electronic and paper submissions.
With eCTDmanager, you are able to build, view, validate and publish compliant submissions based on eCTD, NeeS, eCopy, IMPD, CTA, PIP, VNeeS, DMF, ASMF and other regional formats. eCTDmanager significantly improves the quality and consistency of your submissions, proving a powerful hyperlinking and bookmarking engine that allows the detection, notification and correction of broken links. Sophisticated Structured Product Labeling (SPL) capabilities also enable data entry and maintenance of product information.
eCTDmanager enables you to streamline your global submissions by ensuring full compliance with ICH and regional specifications.
An integrated solution that simplifies your pharmaceutical lifecycle management
As the trusted validator used by more than 35 authorities, eCTDmanager goes beyond a basic eCTD submissions tool. It also provides you with a complete regulatory dossier assembly environment that enables your organization to operate in a compliant manner within a heavily regulated environment. Its intuitive interface enables you to easily handle electronic submissions without prior knowledge of XML-technology, and its unique visual aids provide context, ensuring simplified completion and unprecedented accuracy.
eCTDmanager provides DMS integrations with BIOVIA, EMC² Documentum, Microsoft SharePoint, OpenText, Veeva and several other document management systems.
Available both as an in-house or hosted solution, eCTDmanager enables your organization to be prepared for upcoming regulatory and technical changes, like the introduction of future standards such as eCTD 4.0.
Trusted by over 35 regulatory authorities worldwide, EXTEDO’s submission management suite reduces the time and effort involved in generating, publishing, managing and (re)-viewing validated electronic submissions.