GlobalSubmit’s REGISTER places equal weight on the information going in as it does the information going out. Each product is a global portfolio is associated with a great deal of intricate information — formulations, indications, package description, license number, and dosage strength. REGISTER captures the information regulatory agencies have deemed to be important and then makes it simple for the end user to generate an output, such as Establishment Registration, based on that information.
Gathering all of these product and manufacturing details in one system, deployed in GlobalSubmit’s Secure CLOUD for anytime, anywhere access, gives regulatory professionals unprecedented visibility to information that was previously locked away in offline spreadsheets or paper archives.
As is true for all GlobalSubmit RIMS products, REGISTER users are able to filter by criteria such as product and regulatory agency to create a custom view that is aligned to specific job roles. The solution adjusts to the end user; no longer does the end user need to work around the limitations imposed by the system.
The Application Details module is a central, formal technology solution for capturing, managing, and then re-using information regulatory agencies require such as, but not limited to, formulation, packaging, labeling, and approval dates. As compared to cumbersome spreadsheets and paper archives, Application Details is a user-friendly system that aligns agency requirements to your output. Information can be secured, shared and easily resourced across a global operation.
CMOs that produce the majority of drug products for the industry do not prioritize creating easily manageable regulatory content. Often, their data is cluttered with unimportant details. The Manufacturing Details module focuses solely on the regulatory content needed to support product filings. The platform filters out the noise typically found in manufacturing-based management systems. Regulatory professionals will easily be able to identify the Establishments that produce products/substances and locate source data needed for eCTD and SPL submissions.
- Aligns drug agency requirements with reports output
- Capture labeling and packaging information, product approval and expiration dates, approved indications and your formulations
- Custom filters to locate just the information needed to support product filings
- Locate source data needed to build SPL submissions
- Very detailed information representing global product portfolio must be captured and re-used
- Information locked away in spreadsheets, paper archives or longest tenured employees
- Third party vendors for drug substance and drug products don’t prioritize creating manageable regulatory content
- Missing source data for SPLs