eCTDmanager - Complete Regulatory Dossier Management and eCTD Software

Manage, publish and validate multi-region eSubmissions and product dossiers

The need to build, view, validate and publish eSubmissions based on standardized submission formats like eCTD from multiple regions comes with its own set of challenges.

eCTDmanager is a scalable, all-in-one submission management software solution that meets the requirements for both electronic submissions, such as eCTD and NeeS, and paper submissions.

With submission requirements differing from region to region, the process of creating and managing regulatory submissions on a global scale can be complex and costly. In addition, the lifecycle of a submission may vary from region to region, meaning that documents may need to be independently replaced, added or deleted across many different countries.

EXTEDO eCTDmanager is a software solution designed to maintain a comprehensive overview of your regulatory submission statuses across a number of products within multiple different geographic markets. This helps you ensure compliance and manage your eSubmissions across multiple countries, requirements and conditions.

Benefits

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.

“eCTDmanager was by far the most user friendly, most functional, intuitive and cost-effective solution we found on the market”

Lian Qingling, responsible for international registrations at Qilu Antibiotics (Linyi) Pharmaceutical Co.

Read the related customer success story

"eCTDmanager´s incredibly user-friendly interface and intuitive design enabled us to operate without dedicated IT support. The EXTEDO team was remarkably supportive, effective and professional throughout our cooperation!"

Regulatory Affairs Director at Guangzhou Henovcom Bioscience Co. Ltd

Learn more about EXTEDO eCTDmanager

"After the implementation of DOCmanager and due to the parent-child-concept, expenditure of time for an international dossier rollout has dropped from 6 months to 1-2 months"

Director, Regulatory Informatics and Submission Management at a top 30 pharma company

Learn more about EXTEDO DOCmanager

"Since the EXTEDO solution is easy to use the training process went smoothly. We were working on compiling dossiers almost immediately after the installation."

Quality Assurance & Regulatory Affairs Manager at PHF SA

Learn more about our training offerings

The most comprehensive eCTD management software solution available

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.

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An integrated solution that simplifies your lifecycle management

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.

Save time and costs for validation and compliance

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.

Streamline and maintain global submissions with the DOCmanager module

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.

Export and submit clinical studies in any eSubmission management tool with the RLPmanager module

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.

Resources

Services

Business Process and Regulatory Consulting Services

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.

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