NEWSWIRETODAY Press Release& Newswire Distribution | HOME
MOST TRUSTED NEWSWIRE PRESS RELEASE DISTRIBUTION
PRTODAY / NewswireToday press release distribution service network
More news: Software
Written by / Agency / Source: Octagon Research Solutions, Inc.
Check Ads Availability|e-mail Article

Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

Octagon Successfully Completes eCTD Pilot to Health Canada - News Facts, Octagon Research Solutions, Inc. today announced that its Regulatory team successfully completed the eCTD (electronic Common Technical Document) pilot program for the Health Protection Branch (HPB) of Health Canada
Octagon Successfully Completes eCTD Pilot to Health Canada

 

NewswireToday - /newswire/ - Wayne, PA, United States, 2010/02/10 - News Facts, Octagon Research Solutions, Inc. today announced that its Regulatory team successfully completed the eCTD (electronic Common Technical Document) pilot program for the Health Protection Branch (HPB) of Health Canada.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Software Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

• As a result of successful completion of the pilot, sponsors may now utilize Octagon’s Regulatory services to generate New Drug Submissions (NDS) in eCTD format for submission to Health Canada without the need to submit a sample submission.
• Octagon’s Regulatory Services clients may reference Octagon’s sample submission in lieu of producing a pilot submission, thereby saving time in the overall submission process and in the transition to the eCTD submission format.
• Sponsors may still be required to conduct a pre-submission technical meeting with the agency as described in Health Canada guidance documents without the necessity for a sample submission.

Supporting Quotes

• Patrick Thomas, associate director, Global Regulatory Affairs, Octagon Research Solutions, Inc. noted, “Successful completion of this pilot enables us to save our clients time and resources as they prepare to submit in eCTD format. The pilot experience also adds to our organizational understanding of the nuances of filing in the eCTD format.”
• Nancy Smerkanich, vice president, Global Regulatory Affairs, Octagon Research Solutions, Inc. added, “Health Canada has been moving quickly to support acceptance and review of regulatory submissions in eCTD format and have gained efficiencies in their review process. We expect the agency to continue to gain efficiencies as a result of electronic filings in eCTD format.”

Supporting Resources
• Health Canada
• Octagon’s Regulatory Affairs Consulting.

About Octagon Research Solutions, Inc.

Octagon (octagonresearch.com) is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Harrow, UK. Octagon’s EDC Operations are located in Mountain View, CA.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Software Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: Octagon Research Solutions, Inc.

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick NewswireToday Visibility Checker

 

Distribution / Indexing: [+]  / [Company listed above is a registered member of our network. Content made possible by PRZOOM / PRTODAY indexing services]

 
 
# # #
 
Software Warnings - IMPORTANT:
Always be aware/cautious about what you download on your computer/mobile! PURCHASE SOFTWARE related keywords / Banner Ads. Click HERE for details!
.

 
  Your Banner Ad showing on ALL
Software articles,
CATCH Visitors via Your Competitors Announcements!


Octagon Successfully Completes eCTD Pilot to Health Canada

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name NewswireToday and LINK as the source.
 
Publisher Contact: Kathleen Bouldin - OctagonResearch.com 
610-535-6500 kbouldin[.]octagonresearch.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Octagon Research Solutions, Inc. securities in any jurisdiction including any other companies listed or named in this release.

Software via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY

Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From Octagon Research Solutions, Inc. / Company Profile


Read Software Most Recent Related Newswires:

Siemens Accelerates IP Validation By 1,000X At Arm Using ML-powered Solido Variation Designer on AWS Graviton2
NetSuite Announces SuiteBanking, the First Cloud ERP to Integrate Fintech into a Unified Suite
KPIT and ZF Form Development Cooperation for Industry-leading Middleware Solution
Quest Announces QoreStor 7.1 to Protect Against Ransomware Scourge and Enhance Cloud Support
WANdisco Announces General Availability of LiveData Platform for Azure
RightITnow Releases ECM 6.0 - Deploy Anywhere Monitor Everything with RightITnow ECM
Oracle Named a Leader for Five Consecutive Years in Gartner® Magic Quadrant™ for Enterprise Integration Platform as a Service
IDC MarketScape Names SAP a Leader for Worldwide Industrial IoT Platforms and Applications in Manufacturing
Rocket Software Acquires Database and Tools Products of Zumasys, Inc. - Companies Partner to Drive Modernization of MultiValue Applications
Bangkok Bank and SAS Counter Money Laundering with Award-winning Global Solution
Siemens Digital Industries Software Announce Latest Release of its Aprisa™ Physical Design Solution
SAP Positioned as A Leader in the Gartner Magic Quadrant for Enterprise Integration Platform-as-a-Service
Asda Accelerates Multi-Channel Transformation Strategy with Blue Yonder
Fanalca Selects Infor CloudSuite WMS to Support its Growth Strategy
TIBCO Named A Leader in Enterprise iPaaS by Leading Independent Research Firm

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  Mokuyobi

Visit  La Bella Bakery Artisan Bakery Arizona





 
  ©2021 NewswireToday — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com newswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are proudly NOT affiliated with USA TODAY (usatoday.com)