Quantcast
Last updated on April 21, 2014 at 5:21 EDT

Latest Electronic Common Technical Document Stories

2014-02-18 08:31:46

SAN DIEGO, Feb. 18, 2014 /PRNewswire/ -- CUSTOpharm Regulatory Services, today announced that it has acquired Aspire eCTD LLC, an eCTD publishing software company. Aspire eCTD will expand CUSTOpharm Regulatory Services' portfolio of products and extends our regulatory services by connecting the service and the software as a comprehensive regulatory solution for the pharmaceutical and biotech industries. The two companies have long shared a close relationship since Aspire's inception...

2014-01-31 08:25:44

SAN DIEGO, Jan. 31, 2014 /PRNewswire/ -- CUSTOpharm, Inc. is pleased to announce the creation of two specialty divisions focusing on the two primary focuses of the company since its inception. "The creation of the development and regulatory group as two free standing organizations will allow us to serve our customers better and focus on the ever changing landscape of the FDA," said Dave McCleary, President of the CUSTOpharm Development Company. The Development Company will reside...

2013-11-21 23:25:34

Debenu is a genuine Technology leader, providing PDF solutions worldwide for leading Pharmaceutical businesses over the last decade, among its customer base are Pfizer, GlaxoSmithKline, Abbott and the U.S FDA. Debenu supports the efforts by all organizations to save time and money by building software adopting the best practices in Regulatory Electronic Submissions. Melbourne, Victoria (PRWEB) November 21, 2013 Debenu, released a Pharmaceutical Grade PDF software specializing in...

2013-09-26 23:00:58

Discussion to Address Emerging Standards, New Regulations and Best Practices in Changing Data Environment Horsham, PA (PRWEB) September 26, 2013 The DIA conference EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context will explore how to manage electronic clinical data that are generated in the course of the drug development life cycle while adhering to changing regulatory standards. The meeting, to be held Oct. 15 to 17 in San Diego at the Town and Country Resort Hotel, will...

2013-05-16 23:29:28

The Study Data Reviewer´s Guide Template, a creation of the FDA/PhUSE Working Group collaboration is now available. The Study Data Reviewer´s Guide documents, in a human-readable way, data life-cycle decisions to aid the FDA review of licensing applications. Silver Spring, MD (PRWEB) May 16, 2013 PhUSE announces the availability of the Study Data Reviewer´s Guide (SDRG) Template. The FDA is currently reviewing the implementation/utility of this document and encourages...

2012-12-19 08:26:03

LONDON, December 19, 2012 /PRNewswire/ -- MacPractice launches ePrescribe, VASCO announces eID integration and LORENZ releases groundbreaking eCTD workstation MacPractice, a leading provider of client-centric Apple products for the medical industry, has announced the launch of its brand new ePrescribe application [http://www.prnewswire.com/news-releases/macpractice-iehr-app-for-ipad-and-ipad-mini-with-eprescribe-released-184008851.html ] , giving iPad and iPad...

2012-12-18 16:27:31

PHILADELPHIA, Dec. 18, 2012 /PRNewswire/ -- LORENZ Life Sciences Group launched today their groundbreaking new offering in the US market - docuBridge ONE, the eCTD Workstation Solution. docuBridge ONE is a token-based, single user eSubmission solution downloadable to a user's workstation from www.lorenz.cc in less than five minutes. "The eCTD expertise we have amassed through having LORENZ docuBridge used in hundreds of companies spanning the globe is now packaged as an affordable option...

2012-11-13 08:35:34

FALLS CHURCH, Va., Nov. 13, 2012 /PRNewswire-iReach/ -- Preparing for the New Electronic Submission Mandates:Mastering the Tools and Strategies**Presented by FDAnews and e-SubmissionsSolutions.com**Dec. 6-7, 2012 - Raleigh, NC (Photo: http://photos.prnewswire.com/prnh/20121113/CG11278) www.fdanews.com/eCTD Electronic submissions are going global, and the FDA is leading the way. If you understand the FDA's requirements, you can satisfy any regulator worldwide. This two-day interactive...

2012-10-01 23:02:35

Durham, NC, Thursday, October 4th – Cato Research and GlobalSubmit will cohost another educational webinar on electronic regulatory submissions in eCTD format. Durham, NC (PRWEB) October 01, 2012 The FDA will mandate electronic submissions in the next few years. At the same time, they and other regulators are looking to upgrade the eCTD standard. Why would the FDA mandate electronic submissions and change the standard at the same time? Jason Rock, Chief Technical Officer at...

2012-08-16 02:25:17

PHILADELPHIA, Aug. 16, 2012 /PRNewswire/ -- GlobalSubmit Inc., (www.globalsubmit.com) a leading developer of software designed exclusively to publish, validate, and review electronic Common Technical Document (eCTD) global submissions, announces the expansion of its service offerings with the opening of an office and key new hire in San Diego, CA. Under the direction of Emily Onkka, Director of Project Management and Regulatory Operations, the new office will increase GlobalSubmit's ability...