Expert Services for Foreign Companies Doing Business in the U.S.
Regional Compliance for EU, Australia, and Swissmedic
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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.
GlobalSubmit offers regulatory services to complete all aspects of an eCTD submission. 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 partners. Our 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.
Regulatory compliance is quite complex and the best systems achieve this complexity without burdening the user. The design of GlobalSubmit’s document management suite is informed by our team’s intimate knowledge of government agency requirements and procedures. Our COLLABORATE system is built on the most secure CLOUD platform on the market – Amazon Web Services (AWS). The system is FedRAMP compliant without any additional configuration.
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 firstname.lastname@example.org 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 email@example.com. 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.
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