Latest Electronic Common Technical Document Stories
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 sponsors to...
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...
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...
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...
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...
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...
PHILADELPHIA, July 18, 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 release of GlobalSubmit Cloud, a web-delivered solution of the GlobalSubmit suite. GlobalSubmit takes the industry's leading eCTD platform to new heights by combining the extensive capabilities of its flagship application into a...
DUBLIN, Ohio, March 21, 2012 /PRNewswire/ -- The Scientific and Regulatory Consulting Services business of Cardinal Health Specialty Solutions, previously known as Beckloff Associates, announced today that over the past five years it has submitted 1,000 electronic Common Technical Documents (eCTDs) to the U.S. Food and Drug Administration (FDA) on behalf of more than 200 clients, worldwide. Since its introduction in 2003, the eCTD has rapidly become the format of choice for drug...
HORSHAM, Pa., Jan. 10, 2012 /PRNewswire/ -- LIQUENT, Inc. the global leader in regulatory information management solutions and services, is pleased to announce LIQUENT's XEVMPD Educational Series and Data Assessment tool. Both are designed to assist in complying with the July 2012 deadline for submitting product information in eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) format. LIQUENT's XEVMPD Educational Series is designed to educate internal personnel...
HORSHAM, Pa., Sept. 12, 2011 /PRNewswire/ -- LIQUENT, Inc. the global leader in regulatory information management solutions and services, is pleased to announce LIQUENT InSight® for Registrations XPress Edition. LIQUENT InSight® for Registration XPress Edition is the latest release of LIQUENT's regulatory information management platform. LIQUENT InSight® provides clients with global registration management and submission planning capabilities with a dedicated focus on enabling new...
