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Latest Electronic Common Technical Document Stories

2014-05-12 12:25:28

FALLS CHURCH, Va., May 12, 2014 /PRNewswire-iReach/ -- Preparing for the New eCTD Mandates: Mastering the Tools and Strategies **Presented by FDAnews and e-SubmissionsSolutions.com** June 10-11, 2014 - Bethesda, MD http://www.fdanews.com/eCTDMandatesBethesda Photo - http://photos.prnewswire.com/prnh/20140510/86359 Many drug, biologic and device companies utilizing eCTD can already measure a striking difference through increased first time acceptance rates, shorter FDA review times, speed to...

2014-04-23 23:14:08

Discover the top 10 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions, and the steps drug and devicemakers should take to avoid these conditions in source documents and the eCTD compilation process. This interactive workshop, Preparing for the New eCTD Mandates, will teach tactics and give manufacturers tools to succeed far beyond expectations in the brave new world of eCTD. Falls Church, VA (PRWEB) April 23, 2014 Preparing for the New eCTD Mandates:...

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...


Word of the Day
barratry
  • The offense of persistently instigating lawsuits, typically groundless ones.
  • An unlawful breach of duty on the part of a ship's master or crew resulting in injury to the ship's owner.
  • Sale or purchase of positions in church or state.
This word ultimately comes from the Old French word 'barater,' to cheat.
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