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Welcome To GlobalSubmit


Organizations Worldwide Use Our Software to Ensure Regulatory Approval

Now You Can, Too
 
Obtaining regulatory approval for your new drug is easier when you submit data in the eCTD format Agencies prefer most. GlobalSubmit's Review™ 2009 and Validate™ 2009 give reviewers and applicants a cohesive, comprehensive, XML-unified data view, making submission and approval a lot easier. That’s particularly true if you’re submitting to the FDA, which currently uses our software for its reviewing and validating process. Whether you’re submitting an NDA, an ANDA or an IND, the bottom line is this: when reviewers see your data clearly, they’re better equipped to make informed decisions. That’s good for them and good for you.
 
From the large pharmaceutical organization to the small biopharmaceutical company, eCTD submission is the wave of the future. GlobalSubmit's Review™ 2009 and Validate™ 2009 can take you from here to there. In fact, submissions of all scopes and sizes have already been approved because of the effectiveness of our products.
 
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Announcements
Will Regulated Product Submission (RPS) Trump eCTD? - Tuesday, June 23, 2009

Jason Rock, CTO, answers this very important question in the June 22nd issue of Bio-IT World.  Read more here.

 
Forbes columnist spotlights GlobalSubmit - Wednesday, June 17, 2009

Sramana Mitra, author, strategic consultant and Forbes columnist, spotlights GlobalSubmit in her Deal Radar Blog.  Here, she talks about how GlobalSubmit bootstrapped its way to the top.

 
Jason Rock Quoted in Bio-IT World - Tuesday, June 02, 2009

Jason Rock, CTO of GlobalSubmit explains how RPS will impact eCTD. “The next major version of eCTD is going to transition to the RPS standard. The same content submitted in eCTD, such as the PDF documents and the SAS datasets, will be submitted in RPS, but the inner workings of XML will be completely changed.”

According to Rock, by September 2012, FDA must have RPS implemented because it has Prescription Drug User Fee Act (PDUFA) commitments for two-way communication, and is planning on using RPS to meet those needs. The next milestone is January 2010, the date by which standards are to be in Draft Standard for Trial Use (DSTU) form, or ready for implementation on a trial basis. FDA is slated to develop an RPS Implementation Guide by the end of 2010, and expects to be able to accept RPS Release 2 submissions in spring 2011.

Read more…

 
Current News

 

May 29, 2009

 
GlobalSubmit to Develop Software that Investigates the Use of the HL7 Format for Exchanging and Comparing Study Design Information
  

 

February 20, 2009

 
Anticipates Rejection Of As Many As 5% of All Sequences
  

 

 

Resources

myGlobalSubmit™

myGlobalSubmit is your portal to premium GlobalSubmit web services. Whether you are a current client or would just like to stay informed about eCTD, you will gain access to many valuable benefits by registering for myGlobalSubmit.  

ANYTIME PRESENTATIONS

Stay informed about the latest developments in regulatory by viewing prerecorded presentations by industry leaders. This new service offers insights into the direction of electronic submissions. The first topic is Regulated Product Submissions (RPS).

XFORMS

GlobalSubmit is pleased to be the exclusive host for US FDA XForms!  Use XForms to create small, no-cost electronic submissions to the FDA. XForms is the answer!

 



 
 
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