Comply with regulatory requirements worldwide
Cut down on review, approval and delivery times to market for all of your products
Use advanced automation to reduce errors and increase productivity
How many tools do you need to manage your submissions?
Publishing and maintaining regulatory submissions that are compliant with varying regional standards is complex and time-consuming.
- I am overwhelmed by the number of places where data is stored
- We lack the processes, expertise, and infrastructure to scale up
- The day doesn’t have enough hours to complete my regular tasks
- I struggle with the increasing number and complexity of submissions I need to compile
- We are struggling to find a solution that fits into our IT infrastructure
- We do have a very low user acceptance because the current software is not user-friendly and error-prone
- Our processes struggle to keep up with regulatory requirements
Complying with regulatory standards and processes around the world should be effortless.
Complete regulatory dossier assembly environment that enables you to handle electronic submissions without prior knowledge of XML technology.
Handles all common standards
Build, view, validate and publish compliant submissions based on eCTD, NeeS, ACTD, eCopy, IMPD, PIP, VNeeS, DMF, ASMF, Clinical Trial Applications, and other regional formats.
Built-in technical validation ensures your submission is valid according to the latest validation criteria provided by the authorities worldwide.
Keep track of all changes and updates to your submissions.
Your plan to effortless compliance
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We’ll discuss your goals and uncover your challenges with viewing and reviewing electronic submissions.
Get a free consultation
Our experienced business and technical team will outline a solution to solve your challenges.
Ensure effortless submission compliance with global regulations
Ensure compliance and manage your eSubmissions across multiple countries, requirements and conditions.
Streamline your submission management
Creating and maintaining regulatory submissions that are compliant with regulatory standards around the globe is complex and time-consuming.
From authoring and publishing to ongoing management, eCTDmanager streamlines end-to-end regulatory submission processes, enabling organizations to scale their operations and generate error-free, compliant submissions.
Request your personal EXTEDO Software Demo now!
Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.
Available eCTDmanager Modules
EXTEDO DOCmanager Module
DOCmanager is a module that enables users to re-create dossier templates for different submission requirements with a “parent/child” concept. It significantly reduces the time required to update variations.
EXTEDO RLPmanager Module
RLPmanager is a module for advanced report-level publishing. It is designed to optimize 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.