Facilitating Regulatory Submissions
Due to the enormous amount of information in a drug marketing application, regulatory agencies require sponsors to submit applications electronically in formats that facilitate their review, such as the Electronic Common Technical Document (eCTD). To comply to the complexities and requirements of electronic submissions, regulatory teams need to complement their expert staff with software.
GlobalSubmit™ has been at the forefront of developing and leveraging technology in the regulatory space, having launched the first cloud solution for creating and managing regulatory submissions in 2012. Since that time, the company has stayed at the technology forefront providing a secure, scalable, and robust line of cloud-based products. Sponsors that use GlobalSubmit’s software tools have benefited in time efficiency (reported gains of 3x – 10x) and process efficiency.
GlobalSubmit Submissions Management suite consists of solutions to efficiently publish, validate and review eCTD submissions, and manage the bolus of required regulatory information. The integrated suite of products supports on-time regulatory submissions to health agencies:
- GlobalSubmit Publish™ software facilitates creating electronic submissions in eCTD format and NeeS format
- GlobalSubmit Review™ software expedites reviewing electronic submissions in eCTD and NeeS format
- GlobalSubmit Validate™ software loads and validates eCTD submissions and NeeS documents, generating an optimized view of the application as well as error reports
- GlobalSubmit Manage™ tracks the massive amount of information and data within each submission along with detailed regulatory activity status
GlobalSubmit Regulatory Information Management System (RIMS) is a centralized, customizable platform that manages the global application information, manufacturing details, submission planning, regulatory activity status, agency correspondence, and agency commitments across a product or portfolio of products. Containing six modules, RIMS has three main products:
- GlobalSubmit Communicate™ manages regulatory agency correspondences and achieving agency commitments
- GlobalSubmit Manage™ provides regulatory operations teams with the high-level data needed to manage present and future workloads so that resources can be allocated to the highest priority submissions
- GlobalSubmit Register™ aligns regulatory agency requirements with specific reports outputs, such as labeling and packaging, formulations, and product approval detail
Ensuring Speed and Quality in All Submissions
The ever-changing complexity of regulatory requirements, increasing bolus of required and scientifically rich data and information, and shift to electronic submissions are driving the need for sophisticated and expert services to meet critical operational deadlines. Synchrogenix leverages the GlobalSubmit technology platform along with its expertise in strategic regulatory writing and science to provide full-service project management capabilities for global regulatory submissions. These regulatory and publishing services for marketing and pre-marketing applications will help clients compile an original submission and perform submission maintenance.
To achieve the speed, accuracy, and consistently high-quality expectations of clients, we focus on specific goals:
- End-to-end connectivity and preparedness
- Emphasis on structured data and content reuse
- Delivering increased efficiency by leveraging technology throughout the process
- Using our deep regulatory and scientific knowledge to identify and address critical gaps
- Nimbly integrate the myriad data and information streams from a wide range of disciplines
Regulatory Operations Consulting
Our team of experts will work to streamline your existing submission process and share eCTD best practices. We work alongside sponsors to map and manage the eCTD submission process, identify and address potential roadblocks that may impact the timing and/or quality of your submission, and configure/optimize the technology to meet specific goals. By providing visibility into all aspects of regulatory submission projects, we have built a proven model for communication, internal accountability, and improved client satisfaction.
- Full service project management for submission compilation and support (oversight and expert guidance)
- Team available for client outsourcing, including submissions publishing, validation, management, and tracking (full-service or internal support during peak periods)
- Access to status tracking and submissions review (overall QA and dashboard activities)
Outsourcing Aligned to Program Needs
Outsourcing submission and publishing services are particularly helpful for small to mid-size businesses who are dealing with the following circumstances:
- Filing multiple submissions in a short time period
- Small regulatory team with competing priorities
- Staff with an understanding of eCTD concepts, but little to no hands-on experience
- Converting from paper to eCTD
- Concerns about expenditures to bring on and train new personnel
- Facing risk—and anticipating benefit
GlobalSubmit, now part of Synchrogenix and Certara, provides software and accompanying services for regulatory operations professionals to publish, manage, validate, and review electronic submissions (eCTD). With the investment in technologies and integration into our proven processes, we’ve lowered project costs for our clients while delivering high quality submissions, each time.
- GlobalSubmit 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.
- GlobalSubmit Regulatory Information Management System (RIMS) is a centralized, customizable platform that manages the global application information, manufacturing details, submission planning, regulatory activity status, agency correspondence, and agency commitments across a product or portfolio of products.
End-to-end Regulatory Submission Operations