Datafarm Responds to Health Canada's Announcement of Hybrid eCTD Submission Procedural Simpl...(cent announcement by Health Canada will ...)

Date:11/9/2009

cent 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

0 GOOD

Page: 1 2
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