A centralized, customizable platform that manages global application information, submission planning, regulatory activity status, agency correspondence and agency commitments across your entire portfolio of products.
Proven end-to-end paradigm focused on global regulatory and communications strategy, science, and solutions that truly spans the regulatory continuum, from discovery to patient care.
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Submit your Application On Time or Ahead of Schedule
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.