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eCTDmanager - eCTD Management Software Solution
Reducing the expense of managing compliant electronic submissions
The effective management of validated and compliant eSubmissions is a complex process. The need to build, view, validate and publish eSubmissions based on standardized submission formats comes with its own set of challenges. In addition, managing submissions in multiple regions also requires that all submissions must be compliant with the ICH and regional specifications, which further complicates the overall process.
To ensure compliance, you need an eCTD software solution that enables you to maintain a comprehensive overview of your submission statuses across a number of products within multiple different geographic markets. EXTEDO eCTDmanager is designed to meet exactly these needs and ensure effortless compliance with regulatory requirements.
- Rapid compliance with latest regulatory changes worldwide
- Ability to validate and publish submissions from a single application
- Improves submission quality and consistency
- Supports publication of eSubmissions and paper-based submissions in structures and formats for all regions of the world
- Prepared for future standards like eCTD 4.0
- Supports parallel work locally and worldwide
- Sophisticated management of hyperlinks and bookmarks
- Conforms to ICH and regional filenames and 21 CFR Part 11
- Minimal hardware requirements, rapid deployment and system validation, high performance and minimum training
“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.
"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
"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
"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
The most comprehensive eCTD management software solution
eCTDmanager provides you with a complete regulatory dossier management and assembly solution. Its scalable, all-in-one submission management capabilities meet the requirements for both electronic (like eCTD) and paper submissions.
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. eCTDmanager significantly improves the quality and consistency of your submissions, proving 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 Labeling (SPL) capabilities that also enable data entry and maintenance of product information.
eCTDmanager is a software solution that enables you to streamline your global submissions by ensuring full compliance with ICH and regional specifications as well as electronic submission gateways such as the EMA and FDA gateways.
An integrated solution that simplifies your pharmaceutical lifecycle management
As the trusted validator used by more than 35 regulatory authorities, eCTDmanager goes beyond basic eCTD submissions software. It also 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.
eCTDmanager provides DMS integrations with BIOVIA, Generis, MasterControl, Microsoft SharePoint, OpenText/Documentum, Veeva and several other document management systems.
Available both as an in-house or hosted solution, eCTDmanager enables your organization to be prepared for upcoming regulatory and technical changes, like the introduction of future standards such as eCTD 4.0.
Trusted by over 35 regulatory authorities worldwide, EXTEDO’s submission management suite reduces the time and effort involved in generating, publishing, managing and (re)-viewing validated electronic submissions.
eSubmission, eCTD and RPS Process Services
In order to maximize profitability, modern pharmaceutical organizations need to be able to register products as quickly as possible whilst ensuring compliance with a variety of global regulations. With the high costs associated preparing regulatory submissions it is essential that the compilation and publishing processes are fully optimized. EXTEDO can help you with this.
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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.
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Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
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