PRTODAY / NewswireToday Free press release distribution service network

More news: Software
Written by / Agency / Source: Extedo, Inc.

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

EXTEDO to Incorporate FDA Validation Rules in 'EURS is Yours' - Upcoming release to incorporate validation rules for US eCTD submissions
EXTEDO to Incorporate FDA Validation Rules in 'EURS is Yours'

 

NewswireToday - /newswire/ - West Chester, PA, United States, 2009/02/11 - Upcoming release to incorporate validation rules for US eCTD submissions.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Software Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

EXTEDO announced today that their upcoming release of EURS is Yours version 2.8 has been extended to incorporate FDA requirements. The addition of these rules will allow sponsors to validate an electronic dossier submission in accordance with the published FDA “eCTD Validation Criteria”.

EURS is Yours is designed for the validation, review, and application lifecycle management requirements of the EMEA and 37 EU national competent authorities (NCAs). While EURS is Yours continues to be the leading validation and review tool for most national authorities in the EU, the addition of the FDA validation criteria will allow sponsors to have a single solution that incorporates the recently published validation criteria of both the EU and US eCTD. In addition, EURS is Yours provides a true multi-user collaborative environment for viewing and annotating dossiers in both pre and post submission phases.

“EXTEDO closely monitors all new or changing guidances and specifications from the ICH, FDA, EU/EMEA, Health Canada and Japan” said Harv Martens, Extedo, Inc. Vice President of Operations for North America and Japan. “Our involvement in the EMEA led EURS Implementation Group and the IRISS Forum ensures that EURS is Yours meets the current requirements in relevant regions.“

EXTEDO plans to release version 2.8 of EURS is Yours in Q2 2009.

About EURS is Yours
EURS is Yours is a multifunctional software solution that serves as an overall eCTD validation and retrieval system. It reports whether a submitted eCTD-based application conforms with the official interpretation of the eCTD format. Furthermore it provides access to submissions allowing the user to search, view or print any required regulatory document.

About EXTEDO

EXTEDO (extedo.com) is a leader in e-Submission solutions for highly regulated industries. With more than 600 customers and over a decade of experience, EXTEDO’s customers have been able to implement a proactive regulatory process that is fast and accurate.
EXTEDO solutions for life sciences are designed to achieve compliance with ICH and regulatory agency requirements for marketing authorizations and pharmacovigilance. EXTEDO enables organizations to bring new drugs to market faster with better quality submissions while proactively managing regulated content, reducing costs, and improving regulatory compliance.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Software Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: Extedo, Inc.

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 
Software Warnings - IMPORTANT:
Always be aware/cautious about what you download on your computer/mobile! PURCHASE SOFTWARE related keywords / Banner Ads. Click HERE for details!
.

 
  Your Banner Ad showing on ALL
Software articles,
CATCH Visitors via Your Competitors Announcements!


EXTEDO to Incorporate FDA Validation Rules in 'EURS is Yours'

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: Paula Hunter - Extedo.com 
484- 881-3124 huntermkt[.]comcast.net
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Extedo, Inc. securities in any jurisdiction including any other companies listed or named in this release.

Software via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From Extedo, Inc. / Company Profile


Read Software Most Recent Related Newswires:

Sydney Adventist Hospital Supports Patient Care with Reliable Document Exchange
PTC Marks 15 Years of Partnering with DoD STARBASE Program for Hands-On STEM Education
Multiple Infor Solutions Placed on the Constellation ShortList™ for HR, Financial and Customer Experience
IBM Announces Major Blockchain Collaboration with Dole, Driscoll’s, Golden State Foods, Kroger, McCormick and Company, McLane Co., Nestlé, Tyson Foods
Cortland Capital Market Services, LLC Adopts Yardi Investment Management
JDRF and IBM Collaborate to Research Risk Factors for Type 1 Diabetes in Children
MasterControl Unveils New Corporate Headquarters
Infor Achieves FedRAMP Ready Status
MyoKardia Reduces VM Backup Budget by 50% with NAKIVO
The Weather Company, an IBM Business, to Integrate Global Flight Tracking Data from FlightAware
ROLI Harmonizes its Global Business with NetSuite OneWorld
Independent Research Firm Recognizes Hexaware as A Strong Performer in Continuous Testing Providers’ Evaluation
Airbus Selects OneLogin
Higher Education Institutions Select Oracle EPM Cloud to Drive Student Success
Splunk Introduces Splunk Insights for AWS Cloud Monitoring

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  RightITnow Ltd

Visit  NAKIVO, Inc.





 
  ©2017 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)