The discovery of the Rosetta Stone helped to solve an ancient ligusitic challenge. ROSETTA eCTD suite of software is the future technology that is helping pharmaceutical companies' transition from paper to electronic submissions, archiving and records management - without having to learn the XML or eCTD languages.

• ROSETTA phoenix - eCTD View

  ROSETTA phoenix is a feature-rich, easy to use eCTD viewer. It provides easy navigation and intuitive lifecycle indicators, multi-document viewing and convenient batch printing. It's fast, portable and no XML knowledge is required. Open a 75-submission application with complex lifecycle operations and a 5,000-document original application in 10 seconds and build the current view simultaneously. Installation and upgrades are as simple as copy and paste. Best of all, it's FREE! Download a copy now.

• ROSETTA sceptre - eCTD validate

  ROSETTA sceptre automates the crucial and tedious process of verifying eCTD submissions. It makes sure submissions are compliant with ICH and regional eCTD specifications, guidance, and industry best practices. The eCTD standard is evolving. The current specifications are written in ways subject to different interpretations. ROSETTA sceptre is designed with this in mind. It provides comprehensive user-configurable validation rules. You can even save customized selections of validation rules as named rule sets for easy recall. And, you can run validation at any level; on a leaf document, section, module, submission or the entire lifecycle of an application. ROSETTA sceptre Enterprise Edition offers semantic validation which validates sponsor-provided attribute values, such as product names or study numbers, against authoritative sources in your organization. More information...

• ROSETTA scribe - eCTD publish

  ROSETTA scribe takes out the mystery. It also takes out the complexity of the eCTD specifications from the assembly and compiling process. Simple drag-and-drop operations build compliant eCTD submissions within the context of the lifecycle of an application and do so in less time. No eCTD or XML knowledge is required. ROSETTA scribe pre-populates submission information from previous submissions; it intelligently extracts document titles and prompts you for metadata only when necessary. Use drag-and-drop to indicate 'append', 'replace' or 'delete' lifecycle operations. Submission templates and attribute mapping allow even faster creation of eCTD backbone files. It also includes ROSETTA sceptre to fully validate submissions, ensuring compliance. More information...

• ROSETTA pyramid - Submissions Archive

  ROSETTA pyramid is the retrieval solution based on EMC Documentum. It is an active archive of a submission (paper or electronic) for immediate retrieval and it is 21 CFR Part 11 compliant. It provides powerful search tools and immediate access to submission documents offering the best defense in the event of auditing, litigation and legal discovery. With the advent of eCTD, the lifecycle of a document isn't final after submission. Reference to a document and lifecycle operations may occur anytime. This changes the notion of an "archived" document as something simply filed away in case it is needed; archived documents must be available for immediate retrieval. ROSETTA pyramid provides automatic indexing for eCTD submissions and includes an embedded version of ROSETTA phoenix to facilitate the navigation of those submissions and the immediate retrieval of their content. Combined with our migration service, ROSETTA pyramid can be your single system for all your company's submission records and documents. More information...

For more information about ROSETTA suite of eCTD software, please click here.