Navigation Links
Datafarm Responds to Health Canada's Announcement of Hybrid eCTD Submission Procedural Simplification
Date:11/9/2009

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.

###

Read the full story at http://www.prweb.com/releases/2009/11/prweb3174844.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related biology technology :

1. MasterControl and Datafarm Launch GxP2eCTD at the DIA 45th Annual Meeting
2. Datafarm, Inc., Announces the Appointment of Daniel F. Orfe to Vice President, Global Regulatory Submission Services
3. China Sky One Medical, Inc. Responds to Concerns Regarding Filed Financial Reports
4. Viral Genetics Responds to Rumors of Imminent FDA Filing and Third Party Press Releases
5. Immucor Responds To FDA Notice
6. Sanofi Pasteur Responds to Nations Need for Hib Vaccine With Increased Supply
7. Amylin Responds to Eastbourne Letter
8. HealthCore Responds to Need for Real-world Health Outcomes Information on Drugs and Devices with Physician Network and Prospective Effectiveness Research
9. NeurogesX Responds to EMEAs Day 120 Questions
10. Icahn Responds to Cornelius
11. Protein Sciences Responds to Emergent BioSolutions Lawsuit
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Datafarm Responds to Health Canada's Announcement of Hybrid eCTD Submission Procedural Simplification 
(Date:10/11/2017)... INDIANAPOLIS , Oct. 11, 2017  VMS BioMarketing, a ... of a nationwide oncology Clinical Nurse Educator (CNE) network, which ... growing need for communication among health care professionals to enhance ... physicians, nurses, office staff, and other health care professionals to ... for breast cancer. ...
(Date:10/10/2017)... ... , ... San Diego-based team building and cooking events company, Lajollacooks4u, has unveiled ... bold new look is part of a transformation to increase awareness, appeal to new ... , It will also expand its service offering from its signature gourmet cooking classes ...
(Date:10/10/2017)... 2017 SomaGenics announced the receipt of a ... RealSeq®-SC (Single Cell), expected to be the first commercially ... microRNAs) from single cells using NGS methods. The NIH,s ... accelerate development of approaches to analyze the heterogeneity of ... techniques for measuring levels of mRNAs in individual cells ...
(Date:10/9/2017)... , ... October 09, 2017 , ... At its national ... Christopher Stubbs, a professor in Harvard University’s Departments of Physics and Astronomy, has been ... a member of the winning team for the 2015 Breakthrough Prize in Fundamental physics ...
Breaking Biology Technology:
(Date:5/6/2017)... May 5, 2017 RAM Group ... a new breakthrough in biometric authentication based on ... mechanical properties to perform biometric authentication. These new sensors ... material created by Ram Group and its partners. This ... transportation, supply chains and security. Ram Group is ...
(Date:4/13/2017)... , April 13, 2017 UBM,s Advanced Design ... will feature emerging and evolving technology through its ... Summits will run alongside the expo portion of the ... panels and demonstrations focused on trending topics within 3D ... design and manufacturing event will take place June 13-15, 2017 ...
(Date:4/11/2017)... , April 11, 2017 NXT-ID, Inc. ... technology company, announces the appointment of independent Directors Mr. ... to its Board of Directors, furthering the company,s corporate governance ... Gino ... we look forward to their guidance and benefiting from their ...
Breaking Biology News(10 mins):