EZeCTD - Home

Electronic Common Technical Document made easy

eCTD solutions help regulatory authorities evaluate submission quickly and accurately to approve pharmaceutical products that could save lives

KubsTech, Inc's State Of The Art "EZeCTD" makes your electronic sumissions as easy as 123!

The current version supported is 1.2

Qualified with Oracle database 11gR2

Sales Contact:-

· Contact Person: Kutumba Lanka

· Address: 22 Tanner Dr, Princeton, NJ 08540

· Phone: 732-355-1639

· e-mail:sales@ezectd.com

Support Contact:-

· Contact Person: Usha Lanka

· Address: 22 Tanner Dr, Princeton, NJ 08540

· Phone: 732-355-1639

· e-mail:support@ezectd.com

In 1997, the ICH M2 group pioneered the use of markup languages (e.g. SGML and XML) for the exchange of structured information. In spite of the objections of SGML experts of the time, saying that it could not be done, this approach has proven to be overwhelmingly successful and has been adopted as the basis for many recent standards initiatives. Most notably, for the pharmaceutical industry, we are seeing similarly evolving standards such as those from CDISC and HL7.

In Europe, there are eCTD related efforts such as the PIM Project and the Part 1A Application. At the FDA, a pervasive vision of an electronic continuum from IND to NDA (and beyond) is driving efforts such as the eIND, the ECG Waveform data standard, and an e-standard for stability data. The recently formed FDA Data Council will guide these various initiatives. Even the US government has recognized the benefits of standards with the creation of the Consolidated Health Informatics group.

The eCTD and related standards will help pharmaceutical companies to control global submissions, product life cycle, time to market and supply chain cost-effectiveness.

Updated 21st November 2011