EXTEDO is the only vendor on the market that is able to cover the complete regulatory landscape, including Product Registration Planning & Tracking, Submission Publishing & Lifecycle Management, Pharmacovigilance Management.
EXTEDO’s Submission Management & Publishing software tools are designed to meet the needs of both the pharmaceutical and crop industry. They cover all global standards like eCTD, NeeS or CADDY-xml. We provide safe and compliant submission and lifecycle management software, which is essential for your business success in the fast changing and highly regulated environment of these industries.
DOCmanager is an extension to eCTDmanager that enables users to re-create dossier templates for different submission requirements with a "parent/child" concept. It significantly reduces the time require to update variations.
RLPmanager is EXTEDO’s advanced report level publishing solution. It is designed to optimise pre-publishing activities and support clinical study departments in managing and publishing clinical and non-clinical study reports that later become part of eCTD or NeeS submissions.
EXTEDO PlantOS is an off-the-shelf solution for regulatory affairs within Crop Sciences. It manages the assembly and compilation of electronic dossiers. It supports the e-PRISM (USA), e-Index (CAN), CADDY-xml (EU) standards.
The time to transition from eCTD 3.2 to 4.0 is growing nearer by the day and at EXTEDO our excitement grows too. Having worked with HL7 and ICH since 2010, we have been involved in the definition and refinement of the standard since its conception. Now we are looking forward to it finally arriving.
Work is already well under way to transition all of the applicable parts of our EXTEDOsuite over to eCTD 4.0, with many new product updates elected over the coming months. Our newer products, such as eSUBmanager, have also been written with eCTD 4.0 support at their very foundation.
You can rest assured, if you have an EXTEDO RIM solution then you are in safe hands and are already well down the path to eCTD 4.0 compliance.