www.canadiandrug.org

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

Marlborough, MA (PRWEB) November 9, 2009 -- Datafarm Inc (http://www.datafarminc.com)., 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 (http://www.hc-sc.gc.ca/index-eng.php)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 (http://www.datafarminc.com/Solutions-eCTD.aspx), 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.

###

This press release has been reprinted from PRWEB per the terms and conditions of the copyright notice.

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

Canada Drugs
Canada online pharmacy and Canada Drugs is the major and record important linked Canadian International Discount Medicine Facility Provider. For nearly a period Canada Drugs and Canadian Online Pharmacy has been a chief online apothecary and has worked to agreement the best package involvement likely for our clients. We pride ourselves on provided that you price to high excellence concession medicine from Canada, as well as over-the-counter crops at the certain bottom reduction price.

Laws Governing Canada Drugs
The production, distribution, possession and import of various drugs and substances in Canada are governed by the provisions of the Controlled Drugs and Substances Act (CDSA). Controlled Canada drugs and substances for medical treatment can be legally obtained only with a prescription from a licensed medical practitioner. Also, a prescription drug can be legally possessed and used only by the person for whom it has been prescribed. A person convicted of trafficking or unlawful possession, export, import, trade or production of such drugs may have to face imprisonment or fine or both in some cases. The safe manufacturing and storing of Canada drugs is covered under the drugs section of the Food and Drugs Act of Canada.

Health Canada approves BOTOX® as prophylactic treatment for chronic migraine
Clinical studies show close to 70 per cent of patients experienced more than 50 per cent reduction in migraine days after one year of treatment MARKHAM, ON, Nov. 14, 2011 /PRNewswire/ - Chronic Migraine sufferers in Canada now have an option to prevent the onset of headaches that occur over 15 days a month and leave patients debilitated. Health Canada has approved BOTOX® (onabotulinumtoxinA) manufactured by Allergan, Inc.

Canadian Pharmacy | Canada Pharmacy | Cheap Lipitor
Canadian Pharmacy offer cheap priced Latin drugs at considerably low prices. Canada Pharmacy offer cheap priced reliable and affordable drugs. Mexican Internation Pharmacy have made possible for every person to buy Latin drugs online easily because Canadian Pharmacy have healed the nations of North American peninsula and Canadian peninsula with the help of these drugs. And now, for the rest of the world Latin meds are available on Canadian Pharmacy. Just call out the name of any drug and that is prepared under supervision of affluent pharmacists. Latin drugs were difficult to buy before online appearance of Canadian Pharmacy because, on the one hand, Latin drugs have been really helping to be healed to American nation and, on the other hand ...

All You Need To Know About A Canadian Pharmacy
In 2006, 80% Americans preferred to purchase and import medicines from pharmacies located abroad. Since then, this figure has been increasing steadily. Nowadays, Americans prefer purchasing medicines from Canadian pharmacies due to the low price of Canadian drugs. A Canadian pharmacy offers drugs at least at a discount of 50%, when compared to pharmacies in the United States. The question that arises here is why does the Canadian pharmaceutical market offer such a huge difference in the prices of drugs?

Canadian Pharmacy - Best Source For Generic Drugs
Canadian pharmacy is a leading pharmaceutical company of not only Canada but it has a major share in the pharmaceutical market of United States Canadian pharmacy is equally popular in US primarily because of one main reason, the cost

Cardinal Health Canada Inc. Mails Offer and Take-Over Bid Circular to Futuremed Shareholders
TORONTO, Nov. 14, 2011 /PRNewswire/ -- Futuremed Healthcare Products Corporation ("Futuremed") (TSX: FMD) and Cardinal Health Canada Inc. ("Cardinal Health Canada"), a wholly-owned subsidiary of Cardinal Health, Inc.