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:4/27/2016)... (PRWEB) , ... April 27, 2016 , ... The Pittcon ... Pittcon 2019. Chuck has been a volunteer member of Committee since 1987. Since ... the board of directors and treasurer and was chairman for both the program and ...
(Date:4/27/2016)... , ... April 27, 2016 , ... ... is pleased to announce the appointment of John Tilton as Chief Commercial Officer.  ... Director and one of the founding commercial leaders responsible for the commercialization of ...
(Date:4/27/2016)... ... ... Global Stem Cells Group CEO Benito Novas announced that Duncan Ross, Ph.D. ... Labs in Miami. , In 2004, Ross received his Ph.D. in Immunology from the ... the suppression of graft vs. host disease (GVHD) under UM Professor Robert Levy Ph.D. ...
(Date:4/26/2016)... (PRWEB) , ... April 27, 2016 , ... ... of Lewis Roca Rothgerber Christie LLP as an associate in the firm’s Intellectual ... and international electrical, mechanical and electromechanical patent applications. He has an electrical engineering ...
Breaking Biology Technology:
(Date:3/15/2016)... , March 15, 2016 ... report published by Transparency Market Research "Digital Door Lock Systems ... Forecast 2015 - 2023," the global digital door lock systems ... Mn in 2014 and is forecast to grow at a ... of micro, small and medium enterprises (MSMEs) across the world ...
(Date:3/14/2016)... NXTD ) ("NXT-ID" or the "Company"), a company ... of a new series of commercials on Time Warner Cable ... .  The commercials will air on Bloomberg TV, Fox Business ... show. --> NXTD ) ("NXT-ID" or the "Company"), ... the airing of a new series of commercials on Time ...
(Date:3/11/2016)... http://www.apimages.com ) - --> http://www.apimages.com ) - ... Images ( http://www.apimages.com ) - Germany . ... new refugee identity cards. DERMALOG will be unveiling this device, and ... Hanover next week.   --> Germany ... the new refugee identity cards. DERMALOG will be unveiling this device, ...
Breaking Biology News(10 mins):