eCTDmanager in the EXTEDOcloud

The most comprehensive eCTD management software solution in the cloud

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 submissions, such as eCTD and NeeS, and paper submissions.

As well as traditional on-premise deployments, eCTDmanager is available in the cloud. Cloud-based deployments (or SaaS platforms) are now becoming the standard deployment model around the globe and the life sciences industry is catching-up fast. A cloud-based approach is ideal for growing businesses, or those with less sophisticated IT infrastructure or technical knowledge. It also fits more established organizations that are looking to outsource their IT and reduce the total cost of ownership (TCO) associated with software applications.

Significantly reduce your total cost of ownership

Cloud instances of eCTDmanager can be quickly established and ready for use within a matter of hours, saving you vast amounts of time and effort at the start of your project – all you need is an internet connection. EXTEDO's hosted solutions also cut away the cost of capital intensive hardware.

With the EXTEDOcloud, we take care of your routine back-ups, system maintenance and periodic upgrades. This eliminates the need to monitor for patches and upgrades and ensures that you always have the most up-to-date application version for your region and business requirements. There is also no need to have dedicated IT or other support staff available to perform upgrades and keep the software running.

On average, our estimates have shown that customers deploying their RIMS solution through the EXTEDOcloud save around 30% year-on-year in comparison to those customers using on-premise deployments.

eCTDmanager in the Cloud Benefits

  • reduced cost associated with shared validation
  • reduction of maintenance and support overheads
  • no specialist IT skills required
  • faster implementation and on-boarding
  • regular, managed operational cost
  • highly available and secure infrastructure

“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

Always validated and compliant

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.

About the EXTEDOcloud

The EXTEDOcloud is the leading SaaS environment for Regulatory Information Management Systems (RIMS). Our software delivery model provides a centrally hosted solution that enables individual customers to connect to their personal tenant within the cloud environment.

Our platform architecture enables us to keep data for each customer physically separated, but at the same time share costs associated within hosting and maintenance. Each application within the cloud is ready-to-use on deployment. No further software installation is required and only customer specific data and the users need to be configured.

Like you, security is of the highest priority and the protection and integrity of your data is paramount to us. Access to each individual instance is available only to users on whitelisted IP addresses and regular penetration tests are conducted by a third-party to ensure no loopholes are left unchecked.
If you have additional questions or are interested in learning more about the EXTEDOcloud, contact your regional EXTEDO sales executive for further information.

Additional solutions available in the EXTEDOcloud include:

  • PcVmanager
  • MPDmanager
  • eSUBmanager

 

Downloads

eCTDmanager in the Cloud Product Information

eCTDmanager Case Study Hepalink

eCTDmanager Case Study Optum

More eCTDmanager Case Studies

An Introduction to eCTD

eCTD 4.0: Objectives, benefits & impact

Cloud-based Computing in the Life Sciences Industry

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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Technical Consulting

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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