Corporate Social Responsibility | Business Wire | PR NewsWire | Marketwire | Realwire | ACN/JCN newswire | 247pressrelease | PRWeb

Datafarm Responds to Health Canada’s Announcement of Hybrid eCTD Submission Procedural Simplification

Posted : Mon, 09 Nov 2009 11:02:16 GMT
Author : PRWeb
Category : Press Release
News Alerts by Email ( click here )
News | Home

Four of the top 10 pharmaceutical giants use Datafarm for production of Hybrid eCTD submissions to Health Canada. Datafarm’s announcement comes on the heels of last week’s 7th Canadian DIA Annual Meeting where Health Canada stated that, effective immediately, sponsor companies may submit Hybrid eCTD regulatory submissions for New Drug Submission (NDS) applications with no prior permission request.

Marlborough, MA (PRWEB) November 9, 2009 -- Datafarm Inc., a world leading provider of high performance electronic regulatory submission solutions for the life sciences industry, today announced that four of the top 10 global pharmaceutical companies as well as emerging and mid-level life sciences companies use Datafarm’s software and services for production and delivery of Hybrid electronic Common Technical Document (eCTD) submissions to Health Canada. Datafarm’s announcement comes on the heels of last week’s 7th Canadian DIA Annual Meeting where Health Canada stated that, effective immediately, sponsor companies may submit Hybrid eCTD regulatory submissions for New Drug Submission (NDS) applications with no prior permission request.

Since 2004, a variety of sponsor organizations have used Datafarm’s eCTD software and services, delivering in excess of 500 Hybrid eCTD submissions to Health Canada. Included in these were approximately 20 original NDS’s and numerous clarifax sequences. Daniel Orfe, Vice President of Global Regulatory Submissions Services at Datafarm said, “This recent announcement by Health Canada will not only benefit directorates reviewers, but will also provide sponsors real time access to their regulatory filing information and a clear picture of their products’ regulatory lifecycle. Datafarm’s breadth of experience uniquely positions us to assist sponsor companies in their transition to Hybrid eCTD submissions,” concluded Dan.

A Hybrid eCTD as defined by Health Canada denotes that a sponsor company may file an eCTD submission and provide hardcopy for only Modules 1 and 2. This reduces paper volumes required for submission, potentially by hundreds of volumes. Prior to last week’s announcement from Health Canada, a sponsor company would need to notify the agency of their intention to file a Hybrid eCTD. The agency could elect to deny the request. Effective immediately, Health Canada will accept Hybrid eCTD submissions with no prior permission request.

About Datafarm Inc. Established in 1997, Datafarm is a world leader in high performance electronic regulatory submission solutions for the life sciences industry. Datafarm’s open, modular technologies and professional services experts enable life sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and compliance to efficiently deliver regulatory reports and submissions. Headquartered in Marlborough, MA, Datafarm has offices in the US, UK, France, and India. For more information, visit www.datafarminc.com. Datafarm is a registered trademark of Datafarm Inc. All other product and company names mentioned herein are trademarks of their respective holders.

###

Share/Save/Bookmark

Article : Datafarm Responds to Health Canada’s Announcement of Hybrid eCTD Submission Procedural Simplification
Print this article
Share this article

Stay Updated

News gadget on your Google homepage
Subscribe to a news feed in Google Reader



Related News

Colossus Minerals Announces Earning a 75% Interest in Serra Pelada Project
TORONTO, ONTARIO -- 11/23/09 -- Colossus Minerals Inc. ("Colossus" or "the Company") (TSX: CSI) is pleased to announce that, pursuant to the partnership agreement dated July 16, 2007 between Colossus and its joint venture partner, Coomigasp, as ame..

North Bay Resources Inc. (NBRI) Files Audited Financial Statements
SKIPPACK, PA -- 11/23/09 -- North Bay Resources Inc. (PINKSHEETS: NBRI) ("North Bay" or the "Company") is pleased to announce that the Company has released its audited financials for fiscal years 2008, 2007, and since inception. The complete repor..

Pacific Asia Petroleum, Inc. Signs Purchase and Sale Agreement Covering Rights in the Oyo Oilfield in Nigeria
HARTSDALE, N.Y. - Pacific Asia Petroleum, Inc. (NYSE Amex:PAP) (the “Company&r

UnitedHealthcare Wins Innovation Award from National Business Coalition on Health for Programs That Improve Consumers’ Health
MINNEAPOLIS - The National Business Coalition on Health (NBCH) gave UnitedHealthcare a 2009 eValue8 Health Plan Innovation Award for programs that help engage physicians and patients to achieve better health outcomes. UnitedHealthcare’s Patient-Centered Medical Home (PC

New Media Lottery Services Partners With eircom.net, Ireland's Leading Telecom Website Portal
DUBLIN, Nov. 23 -- New Media Lottery Services, Inc. (OTC Bulletin Board: NWMD) ("NMLS"), based in Dublin, Ireland and Virginia, USA, the lottery content and systems provider, announced a new two year channel partnership agreement with eircom.net, Ireland's l...

Apache Corporation Selects Lawson Global Human Resources Enterprise Application
ST. PAUL, Minn. - Lawson Software (Nasdaq: LWSN) today announced that Apache Corporation has signed a contract to implement

ProSightMD, Inc. Announces New Allscripts Meaningful Use Guarantee
LOS ANGELES - ProSightMD, Inc., a single-source physician’s administrative support supplier and Certified Allscripts Electronic Health Records (EHR) provider, announces a new Allscripts Guarantee program that guarantees that Allscripts EHR solutions will meet all Meaningful Use certifi

Have your Say
Name
Email
Subject
Your Comment

Enter Verification code
 
  

 
Follow The Earth Times
Subscribe to RSS Follow Earth Times on TwitterNews by email
Share/Save/Bookmark
 
 



 
Subscribe to free Earthtimes
News Alerts by Email Click here
For RSS Feeds Click here
or Create your own RSS

Add to Google Toolbar
Breaking News
Press Releases

 


The Earth Times
News Category

© 2009 www.earthtimes.org, The Earth Times, All Rights Reserved | Privacy Policy
Earth Times accept no responsibility or liability either directly or indirectly for views or opinions expressed in articles or comments.