Press Releases

FDA awards Synchrogenix contract extension for eCTD Management Software

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On June 15th, the United States Food and Drug Administration (US FDA) awarded Synchrogenix a contract extension for the electronic common technical document (eCTD) submission management software:

GlobalSubmit REVIEW™ & GlobalSubmit VALIDATE™

This contract extension provides a continuity in the drug review process and marks the 12th anniversary of the exclusive relationship. Since June 2005, the FDA has solely utilized GlobalSubmit REVIEW™ & GlobalSubmit VALIDATE™ solutions as their eCTD platform.

Synchrogenix remains committed to being a transparent and trustworthy partner. We will continue to create best in class eCTD review and validation software and provide updates as we continue our partnership with the US FDA.

 

FDA upgrades eCTD environment

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FDA upgrades eCTD environment to newest version of GlobalSubmit VALIDATE

The US Food and Drug Administration (US FDA) has upgraded their GlobalSubmit VALIDATE™ suite as of July 10th, 2017 implementing the new eCTD validation criteria for Study Data Technical Conformance.

This upgrade focuses on new eCTD validation changes, including new High Level validation errors including those for dataset validation. If high errors are found, submission(s) will receive a technical rejection and will not be filed with the FDA.

Highlights include:

  • 19 new PDF annotation errors 5062-5082 for Module 1.15
  • Dataset validation errors 1734-1737 for studies in NDA’s, ANDA’s, and BLA’s, starting after December 17, 2016, these errors will not apply for studies before that date. These errors will be effective for IND’s starting after December 17th, 2017
  • Corrected an issue causing VALIDATE to produce a High 2012 error when a checksum was missing from a Module 1 document

Since June 2005, the FDA has solely utilized GlobalSubmit REVIEW™ & GlobalSubmit VALIDATE™ solutions and this partnership was recently extended.

Synchrogenix remains committed to being a transparent and trustworthy partner. We will continue to create best in class eCTD review and validation software and provide updates as we continue our partnership with the US FDA.

Three and a Half Million Application Pages Submitted by GlobalSubmit Regulatory Services Over 30-Day Strech

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Philadelphia, PA – December 22, 2016

Over a 30-day stretch in Q4 2016, GlobalSubmit’s Regulatory Services team submitted an impressive 3.5 million application pages.

Included in that total were 2 New Drug Applications (NDAs) submitted to the US FDA, one of which was submitted as a 505(b)(2). Each NDA represents the first marketing application filed for each company’s lead drug product candidate.

“Achieving such success in the face of multiple large, complex projects whose submission dates fell within days of each other demonstrates the capacity of our Regulatory Services team, our ability to plan long-term, and the level of productivity that’s possible with our software,” said Chief Technical Officer, Jason Rock. “These numbers show that GlobalSubmit is on par with any large-scale CRO from a productivity and resource standpoint.”

Personalized attention is also at a premium for clients who select GlobalSubmit as a regulatory outsourced publishing partner.

“Complications are inevitable in the final days of a major NDA submission project,” Rock added. “Both companies that submitted NDAs with us in Q4 2016 chose to have employees on-site at our Philadelphia headquarters during the submission deadline week to foster communication and create a tighter feedback loop. These projects are the culmination of years of effort and millions of dollars spent in development. Our goal is to get a quality submission in front regulators on time and to provide some peace of mind as the project nears completion.”

GlobalSubmit’s Regulatory Services team has experienced tremendous growth in the past few years and that growth will continue in 2017. We provide Regulatory Publishing services for NDAs, BLAs, MAAs, ANDAs, INDs, and maintenance submissions after the original filing.

You can learn more about our Project Management methodology by visiting http://globalsubmit.com/regulatory-services/regulatory-publishing.

GlobalSubmit 2016 (v10.0) Available to Industry

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Enhancements Focus on System Performance, Regional Updates

Philadelphia, PA – August 22, 2016

GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, announces that GlobalSubmit’s Submission Management Suite 2016 R1 (v10.0) is now available to industry in a variety of deployments.

Development of GlobalSubmit 2016 R1 (v10.0) focused on improving system performance. Enhancements in this area include

  • Quicker system response time when processing large PDF files
  • More rapid open of PDF files in GlobalSubmit Cloud environment
  • 64-bit memory to provide better support for companies working on large, complex submissions with millions of bookmarks and hyperlinks.

The major release also addressed the increasingly global nature of eCTD. GlobalSubmit is committed to supporting all regions that accept eCTD, and this release makes progress toward that goal. GlobalSubmit 2016 R1 (v10.0) is compliant with the following regional specifications:

GlobalSubmit 2016 R1 (v10.0) is available for local installation as well as three (3) cloud deployments—multi-tenant, private, and enterprise.

About GlobalSubmit

Headquartered in Philadelphia, PA, with a satellite offices in Boston, MA, and Research Triangle Park, NC, GlobalSubmit is dedicated to facilitating electronic regulatory submissions between life science companies and regulatory agencies worldwide. In addition to developing software for eCTD Submissions Management, Regulatory Information Management and Document Management, we offer a host of regulatory services. Since 2005, GlobalSubmit has been the sole eCTD software provider to the U.S. Food & Drug Administration. The FDA relies exclusively on GlobalSubmit’s REVIEW and VALIDATE platforms to evaluate the technical validity of 100% of the electronic submissions it receives.

GlobalSubmit to Exhibit at 2015 RAPS in Baltimore

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GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulatory submissions, will exhibit at the upcoming RAPS Regulatory Convergence in Baltimore, MD October 24-28. GlobalSubmit is located at booth #113 in the Baltimore Convention Center.

While RAPS is a unique opportunity to showcase GlobalSubmit’s history of developing disruptive technology, recognized first with the 2010 Best Practices Award in Clinical Trials for its effort alongside FDA to spur eCTD adoption, it’s also a time to listen to the challenges confronting the life sciences regulatory community.

“Done right, technology solves problems and creates efficiencies,” Rahul Mistry, CEO, said. “Regulations change, internal processes change and challenges multiply. Our mission is not simply to develop the flashiest technology so we can claim the title of next generation. We anticipate the real world regulatory challenges of tomorrow and develop technologies and processes to deal with those challenges today.”

During the exhibition, GlobalSubmit will be discussing and demonstrating technologies and process solutions that have been successful anticipating regulatory challenges, including PUBLISH, Agile publishing and RIMS products.

Careful analysis conducted by GlobalSubmit revealed 80% of eCTD compilation time is spent publishing PDF documents and reviewing hyperlinks. Our PUBLISH software (version 9.0) targets those bottlenecks, for example, auto processing regulatory compliant PDFs the moment you drag and drop the documents into the system, thus trimming the process to 1 or 2 easy steps.

Our Agile approach to regulatory submission publishing has resulted in projects being completed ahead of schedule 75% of the time without sacrificing quality.

Finally, the upcoming release of products to manage regulatory information will give end users tools to collect, track and act upon critical submission and health agency data without burdensome complexity. GlobalSubmit COMMUNICATE and MANAGE are set for release in Q1 2016 and include modules for agency correspondence, agency commitments, submission tracking and monitoring regulatory status. REGISTER, expected availability in Q2 2016, includes modules to manage application and manufacturing details.

“We consider ourselves innovative and ahead of the curve from a technology and process standpoint, but we also root our efforts in practical, real world regulatory problem solving,” added Mistry.

GlobalSubmit 2015 Available to Industry; Adds Productivity, User Experience Enhancements

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GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, announces that GlobalSubmit 2015 R1 is now available to industry in a variety of deployments.

GlobalSubmit 2015 R1 is the production version the U.S. Food & Drug Administration will implement in support of the new Module 1 specifications (DTD 3.3) plus enhanced functionality for PUBLISH users.

“We are proud of the performance enhancements in this release and the real gains in efficiency and ease of use they represent to our user community,” said Chief Technical Officer, Jason Rock. “Even as our eCTD suite reaches maturity, GlobalSubmit remains committed to innovation.”

PUBLISH is bolstered by two noteworthy innovations.

Any PDF file added to the PUBLISH system can be automatically processed with regulatory compliant properties (Version, Inherit Zoom, Fast Web view, etc.). Built-in PDF compliance is just one example of enhanced functionality GlobalSubmit has introduced in this release by embedding LINK inside of PUBLISH. LINK was previously a standalone product.

Document management systems (DMS) are directly accessible in PUBLISH with GlobalSubmit 2015 R1. A window in the PUBLISH interface patches a sponsor into the DMS file structure for easier drag and drop functionality.

“Never having to leave the PUBLISH interface is a marked improvement in User Experience (UX) and yet another instance of our technology removing a step from the eCTD compilation process to save time,” said Robert Connelly, Product Manager of the eSubmissions Suite.

GlobalSubmit Marks 5th Anniversary of PUBLISH

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GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, is marking five years since the introduction of its eCTD publishing solution.

PUBLISH, now the second most used solution for eCTD publishing, relies on the same engine as our REVIEW technology. REVIEW is an industry staple having processed more submissions than the leading competitors combined, as well as 600,000+ incoming submissions at the US FDA.

Innovative functionality built into PUBLISH greatly reduces the number of complex, manual steps a user must perform during the eCTD publishing process. For example, PDF documents imported to the system are automatically processed with regulatory compliant properties such as Inherit Zoom, version and Fast web.

“There isn’t another publishing system that’s able to deliver equal value to the life sciences community,” said Jason Rock, Chief Technical Officer of GlobalSubmit. “The amount of time PUBLISH can save you in terms of document publishing, link QC, and output processing represents an accelerated approval timeline and treatments available sooner to patients in need.”

The single most powerful innovation PUBLISH earmarks for industry is output processing in a single instance. Real-time identification of validation errors with Live Validation and expedited QC of bookmarks and hyperlinks via CROSSCHECK transform the status quo. PUBLISH also allows for double click editing of PDF documents without breaking the audit trail.

“Our clients and the industry as a whole understand delay of a submission can result in enormous costs,” Rock added. “The publishing system we’ve designed does away with the downside risk associated with publishing out, completing quality review and edits outside of the system, and then having to return to the system to publish. Repeating those steps again and again is simply inefficient.”

GlobalSubmit’s PUBLISH software is available in multiple deployments—local installation, single-tenant CLOUD and multi-tenant CLOUD.

GlobalSubmit 2013 Now Available

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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 the release of GlobalSubmit 2013. The software update features new EU validation criteria and Health Canada’s regional requirements.

This latest release also incorporates the enhanced functionality previously exclusive to GlobalSubmit CLOUD™ into the full software suite available for local use, providing a fully integrated solution that allows users to obtain the status of their submissions in real time. The industry’s first complete web-based eCTD solution, GlobalSubmit CLOUD reduces the internal IT burden and associated costs without sacrificing the quality, performance and support of our software.

“Life science companies must quickly adapt to changes in global regulatory requirements,” stated Rahul Mistry, GlobalSubmit CEO. “GlobalSubmit understands the needs and resource constraints of pharmaceutical and biotech companies, and we address them with GlobalSubmit 2013. The latest installment of our software provides the features and functionality necessary to lead clients toward generating compliant, reviewerfocused submissions quickly and easily.”

GlobalSubmit CLOUD has a number of attributes that make it advantageous to small and mid-sized businesses:

  • Less stress on internal systems and personnel
  • Priority access to software enhancements and regional changes
  • Centralized, secure access to software platforms and documents promotes collaboration by remote users
  • Common sense solution for submission management and archiving
  • Secure enough to gain clearance for use by federal agencies – including the U.S. Food & Drug Administration
  • Public and private configurations available

Expanded Portfolio Centerpiece of GlobalSubmit’s DIA eRI 2015 Exhibit Presentation

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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.

U.S. Food and Drug Administration Implements GlobalSubmit 2010 to Review and Validate all eCTD Submissions

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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.”