Ensure Effortless Compliance using EXTEDO's eCTD Management Software Solution
Managing compliant eSubmissions based on different standards, comes with its own set of challenges including the need to understand and fulfill regional requirements. Some companies have to comply with these regulations globally while other life sciences companies only sell their products nationally. Compliance is essential for any size of life sciences company but with a lot of license models only offering global solutions, small organizations only submitting to one region often struggle with the associated costs for implementing such a solution. Therefore, EXTEDO has designed an eCTDmanager Starter Package that is designed to cure this pain.
eCTDmanager is an off-the-shelf scalable all-in-one electronic submission management solution for eCTD and non-eCTD electronic and paper submissions. The tool enables users to easily build, view, validate and publish (electronic and paper) compliant submissions based on eCTD, NeeS, eCopy, IMPD, CTA, PIP, VNeeS, DMF, ASMF and other regional formats.
The eCTDmanager Starter Package is specifically designed to meet the needs of small, national life sciences organizations. It is a yearly on-premise subscription to eCTDmanager that enables one user to manage an unlimited number of sequences for a single region in all available submission formats. This allows companies submitting to national regions a cost saving, associated with the purchase of an electronic submission software solution. You can choose one of the following supported regions: Europe, China, South Africa, GCC, Switzerland, Canada, Japan, Australia, Thailand and Jordan. During the subscription period, you have access to all eCTDmanager updates including regulatory updates within your region.
The user guide and access to EXTEDO’s eLearning platform allows you to complete a basic product training based on EU best practice. These learnings are easily transferable to your purchased region.
In case you require any kind of regulatory or software usage support, you can benefit from the EXTEDO customer support team expertise. The first 10 software usage and regulatory support cases are already included in the package. This approach ensures effortless compliance for your organization.