eCTD & Electronic Submission Management Solutions Overview
eSubmission Management & Publishing For Life Sciences
EXTEDO’s Submission Management & Publishing software tools for eCTD and other standards are solutions designed to meet the needs of both the pharmaceutical and crop / plant protection industry. 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 software 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.
NeeS & eCTD Submission Validation
Before the scientific merit of a regulated healthcare product can be measured, the submission itself is subject to scrutiny and if during the validation process errors are found, this can delay or prevent the processing of a submission. EXTEDO is the trusted vendor to over 700 customers in 60 countries and has has a 20 year proven track record of successful collaboration with life sciences organizations. As a trusted advisor in the eCTD field, we have developed an electronic submission validation product which guarantees that all relevant validation sets are included and up-to date
EURSvalidator is used by over 35 authorities worldwide, including EMA, to ensure eCTD and NeeS compliance. It enables you to easily validate medicinal and veterinary electronic submissions. EURSvalidator is available in several versions providing functionality and validation sets tailored to your region.
NeeS & eCTD Submission Viewing & Reviewing
The viewing & reviewing of electronic submissions is a key factor in facilitating an efficient rapport between authorities and industry. Submissions need to meet the validation, acceptance, import, review and maintenance requirements of the EMA (European Medicines Agency), the associated national competent authorities (NCAs), and authorities outside of the European Union, e.g. the FDA (US) or the Swissmedic (Switzerland).
EXTEDO has cooperated with regulatory agencies to deliver the best possible solution designed to meet the submission needs of life science organizations.
EURS (EXTEDO Universal Review System) serves as a complete eCTD validation and reviewing solution used by over 35 authorities worldwide, including EMA. It evaluates whether any eCTD- or NeeS-based submission conforms to the mandated standards.
eSUBmanager provides a modern, end-to-end solution that improves the collaborative review process surrounding submission content and metadata in readiness for transmission to the publishing system.
EXTEDO's Support for eCTD 4.0 (RPS)
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.