Rx

Regulatory

Regulatory eCTD

Registration

eCTD Submissions and Registrations Software

MasterControl’s eCTD submission and product registration management software automates, simplifies and accelerates submissions and product registrations.

eCTD submission and product registration requirements vary from country to country. As such, these processes can be time-consuming and nerve-wracking for pharmaceutical and biotech companies. Many countries have adopted the ICH Electronic Common Technical Document (eCTD) standard that harmonizes registration information. However, regional requirements for eCTDs may be different. eCTD submission and registration software gives companies better visibility to manage and configure registrations for faster submissions.

MasterControl Registrations™ for eCTD
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Automate and accelerate your eCTD submissions and product registrations now.

01

Project Visibility

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An eCTD management solution gives you macro and micro views of all your projects for maximum product registration visibility and tracking. An eCTD system ensures you don’t miss critical product registration deadlines.

02

Effective Content Management

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Automated eCTD management software can help you ensure that all documents, data and other artifacts related to submissions and product registrations will be in a single place. Dashboards, checklists and analytics will show the status of every project in real time to simplify the process and make sure you meet complex deadlines.

03

Streamlined Processes

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eCTD software automates manual compilations from teams using various systems to simplify and speed up the document and data management and preparation process. An eCTD system also eliminates data duplication, so you don’t have to compile documents for each region from scratch.

Trusted By

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Learn more about how a registrations and eCTD management solution can save your company time and resources.

The eCTD guidelines are a set of specifications for registration records for medicines. Following ICH eCTD guidelines significantly reduces the time and resources required for compiling applications for product registrations. 

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Find out why a systems approach to eCTD registrations management ensures your submission is controlled, secure and approved.

An eCTD software system provides vital functionalities such as submission-related document templates, secure web-based access to documents, and a mechanism for creating copies of approved submission documents. eCTD software that relies on a system approach can help in preparing compliant eCTD submissions.

After years of work developing a product, don’t stumble when it comes to submissions and registrations.

Managing submissions and registrations for various countries and regions can quickly become chaotic. Learn how to automate and streamline your processes.

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