Manage, publish and validate multi-region eSubmissions and product dossiers
Ensure compliance with regulatory requirements worldwide.
Reduce errors and increase productivity through advanced automation.
Cut down on review, approval and delivery times to market for all of your products.
Validate and publish submissions from a single, cloud-accessible or on-premise application.
Lian Qingling, responsible for international registrations at Qilu Antibiotics (Linyi) Pharmaceutical Co.
Read the related customer success story
Regulatory Affairs Director at Guangzhou Henovcom Bioscience Co. Ltd
Director, Regulatory Informatics and Submission Management at a top 30 pharma company
With eCTDmanager, you are able to build, view, validate and publish compliant submissions based on eCTD, NeeS, ACTD, eCopy, IMPD, CTA, PIP, VNeeS, DMF, ASMF and other regional formats like EAEU. eCTDmanager significantly improves the quality and consistency of your submissions, with a powerful hyperlinking and bookmarking engine that allows the detection, notification and correction of broken links. For FDA electronic submissions, eCTDmanager provides sophisticated Structured Product Labelling (SPL) capabilities that also enable data entry and maintenance of product information.
eCTDmanager goes beyond basic eCTD submissions software. It provides you with a complete regulatory dossier assembly environment that enables your organization to operate in a compliant manner within a heavily regulated environment. Its intuitive interface enables you to easily handle electronic submissions without prior knowledge of XML-technology, and its unique visual aids provide context, ensuring simplified completion and unprecedented accuracy. The in-build technical validation ensures your submission is valid according the latest validation criteria provided by the authorities.
Through our shared validation approach the EXTEDOcloud reduces the time and cost involved in validating your eCTDmanager instance. Within your cloud environment, EXTEDO ensures that your solution is Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validated. Where required, we can provide validation scripts and documentation for your records. The resulting system is validated under FDA 21 CFR Part 11 and EU GMP Annex 11 Volume 4.
Through the use of a parent-child dossier concept, DOCmanager, as an add-on to eCTDmanager, enables you to readily generate responsive templates for multiple submissions through simple country level changes. Any changes you make to the parent dossier are automatically inherited by the child dossier, thus eliminating the need for revalidation. Reuse the content for dossiers based on different submissions scenarios, thus reducing the efforts associated with compiling and maintaining multi-region product dossiers.
The RLPmanager module add-on for report level publishing gives you the power to compile and export files into a single format eligible for submissions in eCTDmanager or any other electronic submission management software. Use drag-and-drop to create, compile, validate and version clinical studies, or edit them at a later date. When you’re ready, you can merge multiple PDF files into a single document, ready for use in any electronic submission.
eCTDmanager enables you to readily build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF and other submission structures. Now you can get to market faster.
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.
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.
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
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.