COMMUNICATE, MANAGE Now Available to Industry
Philadelphia, PA – January 10, 2017
GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in regulatory technology solutions and services to support global life sciences submissions, is adding a pair of regulatory information management (RIM) products to its portfolio.
The RIM products comprise a novel, long overdue solution to a pressing industry need.
“I’m 100% confident these RIM products will change the way Regulatory groups plan, share, and report on product and application information. When integrated with our eCTD software, GlobalSubmit’s RIM suite gives Regulatory professionals a user-friendly, centralized, and web accessible platform to manage, publish, and review all regulatory activities for the first time,” said Product Manager Rob Connelly.
COMMUNICATE tracks health agency correspondences, such as emails and phone calls with regulators, as well as health agency commitments. User can apply filters to sort the information by agency and/or individual product. Information captured in COMMUNICATE can be shared with colleagues and used to build internal reports.
MANAGE, which is integrated with GlobalSubmit’s eCTD Submissions Management suite, takes in vital submission information and associated metadata and gives companies the ability to plan and track activity based on region, product, and application type. MANAGE also produces submission workload insights. Users can use the system to allocate resources, log submission dates, and access submission project plans.
GlobalSubmit’s RIM solutions function as an integrated system yet are available as separate licenses, allowing life sciences organizations to scale and address operational needs as they mature.
COMMUNICATE and MANAGE are available in GlobalSubmit’s hosted cloud deployment, built on Amazon Web Services (AWS) infrastructure.
For a preview of GlobalSubmit RIM products, please visit globalsubmit.com/education/upcoming-industry-events to register for a live production demonstration webinar. Registration is now open.
Three and a Half Million Application Pages Submitted by GlobalSubmit Regulatory Services Over 30-Day Strech
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.
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:
- Australia (TGA) Version 3.0
- European Module 1 v3.0.1
- Swissmedic Module 1 v1.3
GlobalSubmit 2016 R1 (v10.0) is available for local installation as well as three (3) cloud deployments—multi-tenant, private, and enterprise.
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 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 Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, would like to introduce Evan Richardson, Director of Regulatory Services, as the newest member of our Management team.
“For the majority of my career, I’ve been a GlobalSubmit client and an outspoken proponent of their people and technology solutions,” said Richardson. “I’m excited to join and lead a team of experienced professionals in providing world-class eCTD publishing services.”
Mr. Richardson brings 10 years of experience in regulatory affairs and operations to GlobalSubmit. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he’s specialized in project management, system implementation, eCTD submissions, and organizational training.
Prior to joining GlobalSubmit, Mr. Richardson fulfilled a number of responsibilities within the regulatory departments of Bioventus and Cato Research, both located in North Carolina’s Research Triangle Park area.
His career achievements include a major role in the approval of 3 distinct marketing applications, hundreds of regulatory submissions (IND, NDA, BLA, and DMF) and a company-wide launch and implementation of a new document management system.
“Evan is a consummate professional and the depth of his experience in every facet of our industry will be a tremendous asset to GlobalSubmit,” said GlobalSubmit CEO, Rahul Mistry. “We also look forward to extending our base of operations to the Raleigh-Durham area, where Evan has developed sustained and meaningful professional relationships in the past 10 years.”
Mr. Richardson is no stranger to readers of GlobalSubmit’s eCTD Summit blog. His article Transitioning from Paper to eCTD published in September 2011 is one of the most popular articles in the history of the site.
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 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 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
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.”