CAMBRIDGE, MA – 18 October 2007: Virtify is pleased to announce the release of version 2.1, a comprehensive solution for compiling, reviewing, and submitting applications to Life Sciences Regulatory agencies using the Electronic Common Technical Document (eCTD) standard.
<virtx:eCTD> is built on the open architecture of the Virtx platform, a comprising infrastructure and business components common to all of Virtify’s products. This release of version 2.1 of the eCTD product features:
- Comprehensive support for submissions to the United States Food and Drug Administration, meeting all the relevant standards
- Full functionality to create an application and compile, review, and submit sequences available using a multi-user Web interface. This eliminates the problems associated with client side software deployment and enables several users to concurrently work on different parts of a submission The status of documents at different phases is available with appropriate icons, alerts and notifications.
- Roles-based access control and Integration with Active Directory
- Integration with the Livelink Document Management System both for retrieving and storing content
- Optional, additional client side functionality promotes ease of use for file transfer and offline submission browsing.
Virtx eCTD is designed to conform to HL7 and ICH standards. It is a complete web based solution that requires no client side downloads eliminating software deployment complexities involved with upgrades, patches and schema changes. This web based architecture provides a multi-user environment for users to work on different parts of a submission concurrently. The solution provides the status of documents at different phases of the submission with appropriate icons, alerts and notifications.
About Virtify
Virtify is a global company, with headquarters in Cambridge, MA and other international locations in India, Philippines and Bulgaria. We use cutting edge web-based technologies and global delivery capabilities to develop and implement innovative software products and solutions for the Life Sciences industry.
One of our strengths is our deep domain knowledge and demonstrated leadership in emerging global standards. Virtify is one of the first companies to introduce a pure web-based Structured Product Labeling (SPL) solution for managing the entire life cycle of labels. Virtify was the first to submit a SPL demo to the Food and Drug Administration (FDA) and the first company to submit a Regulated Product Submission (RPS) drug device and combination drug submission to the FDA. The first RPS Viewer was also introduced by Virtify we were the first to submit an Electronic Common Technical Documents (eCTD) drug and device submission to the FDA. In addition, we have recently been the first to submit messages in emerging standards such as eStability and ICSR. Such leadership on standards has enabled us to work closely with clients in effectively planning for emerging standards while addressing current mandates and standards for clinical and regulatory submissions.
Virtify’s clients include several pharmaceutical, and biotechnology companies, and its projects have spanned the R&D lifecycle, from discovery through commercialization.. For additional information about Virtify, please visit
http://www.virtify.com.