GlobalSubmit’s Submissions Management suite consists of solutions regulatory operations professionals need to efficiently publish, validate and review eCTD submissions, plus MANAGE, a solution to tie submissions to the bigger picture of regulatory information management. The fully integrated suite of products allows for informed scheduling and on-time delivery of regulatory submissions to health agencies. When integrated with GlobalSubmit’s Registration Management and Document Management suites, GlobalSubmit offers the first truly integrated regulatory information management solution for the life sciences industry that supports the real world work habits of regulatory professionals.
GlobalSubmit offers regulatory submission and publishing services for marketing and pre-marketing applications, as well as subsequent lifecycle submissions (amendments, supplements, and reports) to support those original applications. The depth of our experience and knowledge acquired from our work with the US FDA, ICH, HL7 and industry groups is made available to our clients. Our Regulatory Services team can guide your organization through compilation of an original submission, perform submission maintenance and step in to support your internal staff during workload peaks.
The design of GlobalSubmit COLLABORATE draws from our own industry experience, carefully cultivated over a dozen years facilitating electronic regulatory submissions, and input from professionals who would potentially use the system. The result is an intuitive, affordable document management system that reduces complexity from a user perspective while meeting the same robust standards for security and regulatory compliance as our other technology solutions for pharmaceuticals and biotechnology companies. We’ve take all of the complexities associated with organizing submission documents (metadata, workflows, audit trails, cross references, and more) and directly integrated them into the software.
GlobalSubmit is dedicated to facilitating regulatory submissions between life sciences companies and global regulatory agencies. Our flagship Submissions Management Suite includes solutions for publishing, validating and reviewing eCTD submissions, as well as submission tracking and monitoring regulatory activity status. We have also introduced solutions for life sciences document management and regulatory information management.
We also offer a host of regulatory services including, but not limited to, regulatory publishing, regulatory operations and affairs consulting, data services, migration, medical writing, US Agent service and ESG transmission.
Since 2005, GlobalSubmit has been the U.S. Food & Drug Administration’s sole eCTD software vendor. 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 is committed to providing the highest level of customer support. Our support team is available to help resolve a host of issues including, but not limited to, software usability, configuration, access and performance. We can also assist in more complex matters such as system validation and eCTD system migration. Visit the Product Services page for more information on these services.
Standard customer support is available from 9 a.m. – 7 p.m., Eastern Standard Time, Monday-Friday, with the exception of company holidays. Comprehensive support outside of normal business hours is available on an individual basis.
During the hours of 7 p.m. – 9 a.m. ET, Monday-Friday, GlobalSubmit will offer Tier 1 support. Tier 1 support addresses usability and configuration issues. Examples of this coverage include ‘how to’ software functionality requests, password resets, installation questions, etc.
To open a support case, please call 215-564-3509 or email email@example.com between the hours of 9 a.m. – 7 p.m. For Tier 1 GlobalSubmit from 7 p.m. – 9 a.m. ET, please send an email describing your issue to firstname.lastname@example.org. A support associate will respond to your request via email or phone call.
GlobalSubmit maintains a local presence in many of the major biotechnology centers in the US in an effort to provide more responsive and transparent service to our clients. Please see below for contact information corresponding to each location.
We are headquartered in Center City Philadelphia, just steps from historic City Hall, with regional offices in Cambridge, MA, Research Triangle Park, NC, and San Diego, CA.
Visit the industry’s most read blog offering expert commentary on regulatory submissions