GlobalSubmit to Exhibit at 2015 RAPS in Baltimore
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.