GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, will exhibit its complete portfolio, including early prototype versions of Regulatory Information (RIMS) and Document Management Systems (DMS) at the 2015 DIA eRegulatory and Intelligence Annual Conference.
The conference is being held May 11-13 at the Sheraton Downtown Hotel located in Center City Philadelphia just blocks from GlobalSubmit company headquarters.
“Much like DIA’s leadership has broadened the scope of this conference to encompass all subsets of regulatory information management, we’ve expanded our offerings to serve the entire regulatory market,” said GlobalSubmit CEO Rahul Mistry. “Information destined for regulatory submission travels along a path and all points along that path are related and full of inefficiencies to exploit.”
“When Philadelphia last hosted a major DIA conference in 2012, GlobalSubmit’s flagship products were REVIEW and VALIDATE while our PUBLISH product was growing in popularity,” Mistry added.” Today, our PUBLISH software is an innovative, mature solution that is the second most used publishing solution in the marketplace. We also have a world-class services department and are introducing new products for end-to-end management of regulatory information. GlobalSubmit now provides a complete solution for our clients’ needs.”
GlobalSubmit will be presenting at Booth #102 in the main exhibit hall. Demonstrations of our prototype RIMS and DMS product are available by appointment during the conference.
On the second day of the conference GlobalSubmit’s eSubmission Suite Product Manager Robert Connelly will present “Preparing for the New Module 1 (3.3 Format)” alongside representatives of the FDA and clients who have participated in the FDA’s M1 pilot program. The latest release of GlobalSubmit’s publishing software is in full compliance with the new Module 1 specifications the FDA is scheduled to implement later this year. Mr. Connelly’s presentation is scheduled for Tuesday, May 12 at 8:30 a.m.—10:00 a.m.
GlobalSubmit Inc., (www.globalsubmit.com) a provider of end-to-end software and services solutions for delivering high-quality electronic submissions to regulatory authorities, announces that the company more than doubled its workforce in 2013 and is again poised for growth in the coming year as emerging life science and biotechnology firms seek a trusted partner to supply guidance on navigating a changing industry.
Hiring was concentrated in the electronic publishing department, giving GlobalSubmit expanded capacity to take on multiple, large-scale submission projects simultaneously, while utilizing the industry’s most innovative eCTD software suite. The number of new small business clients added well exceeded projections with many sponsors opting for full eCTD outsourcing services or taking advantage of the convenience and cost savings associated with GlobalSubmit CLOUD™, the industry’s first complete web-based eCTD solution.
The main catalysts for growth in 2014 are the looming mandate to submit in electronic format passed in the Prescription Drug User Fee Act (PDUFA V) and the U.S. Food & Drug Administration’s acceptance of a new Module 1.
GlobalSubmit, the sole eCTD software provider of the FDA, is currently conducting beta testing of the new Module 1 using its CLOUD deployment. This is one of many reasons why the company is confident in its ability to reassure stakeholders in the electronic submissions industry during this turbulent stretch.
“Our partners continue to rely on the performance of GlobalSubmit software and our team’s depth of knowledge,” said Rahul Mistry, CEO of GlobalSubmit. “The trust we’ve built in the industry has positioned us to pursue an aggressive hiring strategy, and the level of talent we’ve accumulated has us excited about seizing even more opportunities for growth in the future.
“Organizations in the user community we serve must cope with the inevitability of the electronic mandate and the acceptance of a new Module 1,” Mistry added. “Not only does our software and industry-best regulatory support give you a chance to succeed out of the gate, we can streamline your overall process and introduce efficiencies you did not know were possible.”
Visitors to GlobalSubmit.com will encounter a streamlined layout that simplifies navigation and showcases the site’s most compelling content – including closer integration with the industry’s most popular blog.
“It continues to be a critical time for our industry,” said Rahul Mistry, CEO of GlobalSubmit. “The FDA’s electronic submission mandate is looming. Our website update is an effort to accurately convey GlobalSubmit’s full capabilities and make valuable resources available to sponsors who need them.”
The company color scheme has also been refined and now features cooler shades of blue and green.
Site content was refreshed to present GlobalSubmit’s full complement of software and regulatory services, and to include industry information relevant to pharmaceutical and biotechnology companies who are either adopting the electronic submission format for the first time or considering new regulatory submission strategies.
GlobalSubmit, a company focused solely on providing end-to-end software and services solutions for delivering electronic submissions to regulatory authorities, commissioned the project to accurately convey its position as a trusted leader in a changing industry.
The association between the industry’s most read blog, The eCTD Summit, and GlobalSubmit’s primary website was brought into closer alignment during the website launch. Branded with a new logo and layout, The eCTD Summit offers commentary from GlobalSubmit’s executives and senior staff.
GlobalSubmit Inc., (www.globalsubmit.com) provider of a full spectrum of software and services that facilitate the delivery of high-quality electronic submissions to regulatory authorities, would like to introduce Bill Taylor, Senior Vice President of Sales and Marketing, as the newest member of our Executive team.
Mr. Taylor’s distinguished career includes more than 25 years in sales, marketing, and general management leadership roles. His achievements include helping companies strengthen their client interactions by improving sales development, customer care functions, and strategic marketing efforts.
“I’m excited to have joined GlobalSubmit, and for the opportunity to strengthen and grow our client relationships – established through steadfast dedication to providing clients with best-in-class service and regulatory submissions solutions,” said Taylor. “I’m proud to be a part of the executive team, supporting the company’s growth strategy to enhance its already enviable market position.”
Mr. Taylor’s clients, customers, and former employers – global leaders in technology, healthcare, private equity, management consulting and professional services – include such companies as Sage, Stryker, J&J Ultrasound, Philips, IBM, Motorola, Panasonic, Verizon, Bain, Boston Consulting Group and McKinsey & Company.
“Bill’s wealth of experience and industry knowledge have already made him a key addition to the GlobalSubmit team,” said GlobalSubmit CEO Rahul Mistry. “We view his appointment as a sign of our commitment to being the leading company in our industry. Our new innovations and the increasing demand from our clients led us to look for an addition to our team who will fit in with our values of client focus, innovation, and exceptional service, and it is very fortunate that we were able to find someone of Bill’s caliber to fulfill this role.”
U.S. Food and Drug Administration Implements GlobalSubmit 2010 to Review and Validate all eCTD Submissions
GlobalSubmit Inc., (www.globalsubmit.com) a provider of end-to-end software and services solutions for delivering high-quality electronic submissions to regulatory authorities, announces that the U.S. Food and Drug Administration (FDA) has installed GlobalSubmit 2010 and is using the software in production to review and validate all eCTD submissions. The release includes several performance enhancements and positions the FDA to receive all submissions electronically.
The FDA is a unique partner with over 4,000 users and more than 200,000 sequences processed. The driving forces behind the FDA’s adoption of the software update were the availability of the latest Study Tagging Files (STFs) valid values, new validation checks, and new views. The FDA looks at GlobalSubmit’s validation reports to determine if sequences are reviewable. Therefore, the use of GlobalSubmit’s validation platform helps sponsors create higher quality sequences.
Cognizant of the FDA’s present and future needs, as well as the increased adoption of electronic submissions industrywide, GlobalSubmit’s latest release incorporates the following performance enhancements:
- Ability to load several thousand sequences a day (current workload is 600 sequences a day)
- Ability to load 200,000 sequences in two weeks
- Ability to prioritize which sequences are loaded first (load priority reviews first)
- Analyze validation reports with different views
- Have a log of every sequence that received a technical rejection
- Effectively prioritize sequences and help to determine where there are errors
“Our main goal with this release is to enable clients to create high-quality submissions quickly and simply,” stated Jason Rock, GlobalSubmit’s chief technical officer. “When we first introduced GlobalSubmit 2010 we were able to load four sequences a minute, or 5,500 sequences a day. This would have taken the FDA about a month and a half to process all of their existing sequences.
“Now we can process 30 sequences a minute, meaning the FDA can process all submissions in less than a week, or over 40,000 sequences a day,” he added. “The combination of our powerful functionality and enhanced performance has helped turn our goal into a reality, and we look forward to rolling out this latest
version to our clients.”
GlobalSubmit Inc., (www.globalsubmit.com) a provider of end-to-end software and services solutions for delivering high-quality electronic submissions to regulatory authorities, announces that GlobalSubmit 2014 Version 8.0 is now available to industry and has been released to the U.S. Food & Drug Administration for testing and validation. The full software suite is available commercially in a number of deployments, including software as a service (SaaS) or Cloud.
Release of GlobalSubmit 2014 to the FDA does not affect the Agency’s live production environment. Review and validation of incoming submissions are being performed in accordance with a previously installed version of GlobalSubmit software.
GlobalSubmit 2014 includes performance enhancements requested by industry and several regional regulatory updates – notably the ability to accept the new FDA Module 1 (M1) specifications. Recognized as the most substantial change in the history of eCTD, the updated M1 introduces two major activities that were previously impossible:
- All electronic submission of promotional and marketing materials via the FDA’s Electronic Submissions Gateway (ESG)
- Grouped submissions – eliminates the need to submit multiple, identical submissions to different applications.
“The inclusion of M1 changes in this release is the culmination of more than a year of development and testing by our team – along with collaboration with industry and the FDA,” said Jason Rock, chief technical officer of GlobalSubmit. “The focus on M1 shouldn’t overshadow the work we’ve done to ensure compliance with worldwide regulatory requirements including EMA and Health Canada. Furthermore, we’ve made numerous enhancements at our clients’ request.”
Adoption of electronic submissions is now prevalent among life science companies. To date, the FDA has processed more than 500,000 sequences. Increased volume of applications requires greater accuracy and performance, and GlobalSubmit has delivered both in this release.
GlobalSubmit Inc., (www.globalsubmit.com) a provider of end-to-end software and services solutions for delivering high-quality electronic submissions to regulatory authorities, announces that the U.S. Food & Drug Administration is conducting beta testing of its new Module 1 using GlobalSubmit’s CLOUD deployment.
Performing the necessary functionality inspections on the CLOUD has provided the FDA with instant access to changes GlobalSubmit is making at the Agency’s request. This feedback loop is moving the project along at a pace that would not be possible with an on-site installation.
“The real time exchange of information between our development team and the FDA has been invaluable for both sides” said Jason Rock, chief technology officer at GlobalSubmit. “Technically, we’ve been able to verify that completed elements function as expected. Creatively, the back-and-forth has resulted in new feature requests and helped Agency officials gather their thoughts pertaining to industry guidance.”
According to a recent notice posted on its website, the FDA estimates it will be able to receive submissions using the new Module 1 specifications in the 4th Quarter 2014. Industry will be given 30 days’ advance notice.
The long awaited update to the eCTD’s administrative section is designed to:
- Reflect regulatory changes
- Provide clarification of business rules for submission processing and review
- Refine the characterization of promotional marketing and advertising material
- Facilitate automated processing of submissions
“This is the biggest change in the history of eCTD,” Rock stated.
One of the most consequential changes included in the new Module 1 will give organizations the ability to register multiple products by submitting a single sequence. For example, if one manufacturing facility is responsible for producing Drug A, Drug B and Drug C, the relationship between that lone facility and multiple drugs can be indicated in one submission. Currently a sponsor must file one submission per product. With the new Module 1 implementation a change made pertaining to the facility after the original submission is filed can be applied to all products.