MasterControl Registrations for eCTD is a solution for product registration and eCTD management that will automate your manual or hybrid processes and track various requirements for every geographic location allowing users to quickly identify content based on region and prepare for electronic submission publishing via a partner or in-house publishing tool of their choice.
Product Registration Challenges
Lacks Project Visibility
When you have multiple products that need to be registered in many countries, you could get mired in the minutiae and lose sight of the truly critical deadlines.
Creates Project Visibility
MasterControl provides the tools to give you a micro and a macro view of projects. You can zoom in on requirements per country or zoom out for a global picture of all markets just as easily.
Granularity is Overwhelming
The variables in requirements increase exponentially with the number of countries at issue and the number of products being registered. Keeping up with the granularity of every registration and re-registration project is overwhelming.
Standardized, out-of-the-box templates will simplify every registration regardless of granularity. The solution provides a powerful tool for customizing unique or complex processes into templates.
Duplication of Efforts
Managing multiple registrations and submissions globally often entails repurposing much of the same content. An inefficient system means repeating the same activities for each country.
Avoid Duplication of Efforts
MasterControl allows the cloning of collections of content to eliminate duplication of efforts. You don't have to compile documents for each region from scratch. This means faster registrations and faster time to market globally.
Ineffective Project Management
Managing timelines and tracking requirements for every country is difficult with just a spreadsheet, which doesn't scale to complexities. This could result in missed deadlines.
Effective Project Management
With MasterControl, all artifacts related to registrations will be in one place for more effective document management. Dashboards, checklists, and analytics will show the status of every project.
Manual compilation of documents from multiple teams using different systems (ERP, PLM) is a painstaking and inefficient process that causes delays in submissions.
MasterControl automates manual or hybrid processes and simplifies the process of compiling, reviewing, and approving documents from different sources. Notification of approaching deadlines will be automatic.