For pharmaceutical and biotech companies, product registration and regulatory submissions requirements in different countries is a time-consuming and nerve-wracking process. Many countries have adopted the Electronic Common Technical Document (eCTD) standard, so registration information is essentially the same. However, regional requirements may be different. Many companies are increasingly using eCTD publishing software to help ease their submission burden.
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.
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Major U.S. federal and state agencies, including divisions of the world's largest and most recognized regulatory agency, use MasterControl. If your company is looking for eCTD software, here's how MasterControl Registrations will help you address common 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.
Stakeholders who use disparate systems face communication challenges and lack the agility to respond to regulatory issues in a timely manner.
MasterControl Registrations can be integrated with the quality management system or other systems to facilitate collaboration.
Different teams focus on customizing registrations to each market, which may result in inconsistent filings. Submission data are fragmented across multiple systems.
Standardized Tools for Consistent Filings
Templates and checklists based on industry standards will foster consistent filings throughout your organization regardless of location. The solution will provide a platform for a unified approach to submissions.
The ICH CTD standard has led to harmonized submissions and eliminated the need to reformat each submission to different ICH (International Council for Harmonisation) regulatory bodies. The FDA adheres to the ICH eCTD standard.
Transparency of Product Registration Projects: MasterControl provides preconfigured, building-block templates (based on ICH CTD standard) to help you launch a registration project fast.
Standardized Processes: Best-practice templates will standardize your submissions and equip your organization with constant readiness and a head start for every registration.
Effective Milestone Management: Checklists will help ensure that stakeholders will meet their requirements within schedule. Approaching or missed deadlines will become glaring
Increased Efficiency: Automation of routing, review, and approval of documents will greatly streamline your workflow and increase your efficiency. Tasks will no longer slip through the cracks with automatic task notifications and timeline alerts.
Connectivity: Registration projects scattered across jurisdictions require close collaboration among multiple teams. MasterControl provides the connectivity to facilitate collaboration among your stakeholders, including consultants and vendors.
If your company is pursuing marketing authorization applications or approval for NDA, IND, or BLA (biologics license application), find out how eCTD publishing software can help you.To learn more about MasterControl's Registrations for eCTD, please contact a MasterControl representative.