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