Introducing NextGen eCTD Software for Your Global eCTD Compliance.
The ultimate solution for your regulatory submission needs. Our advanced NextGen eCTD software provides seamless creation, management, compilation, publishing, review, validation, and archiving of dossiers in fully compliant eCTD format, meeting the highest Regulatory (Regional and ICH) specifications.
NextGen eCTD Publishing tool is a comprehensive software solution designed to streamline the submission process for regulatory documents in the pharmaceutical and healthcare industries. This tool is pivotal in ensuring regulatory compliance and expediting the approval process for new drugs and medical products.
With its availability on both Microsoft Azure Cloud and On-Premises Server, the NextGen eCTD system offers flexibility and accessibility to meet diverse organizational needs and preferences.
Cloud Deployment
On-Premises Deployment
Nextgen eCTD Supporting Countries
United States
United Kingdom
European
Canada
Australia
Thailand
Switzerland
South Africa
Jordan
Gulf CouncilKey Benefits
Streamline & Enhance with NextGen eCTD
Optimized Workflow
Unlock unparalleled efficiency and streamline your operations with our optimized workflow solution. With our cutting-edge NextGen eCTD tool, we empower you to slash publishing time by a remarkable 40%, revolutionizing your regulatory submission process.
All-in-One Publishing Solution
Unlock the full potential of your regulatory submissions with our all-in-one software solution, encompassing eCTD, NeeS, and pCTD publishing activities. Simplify your processes and expedite submissions with our comprehensive NextGen eCTD tool.
Dossier Submission Tracking
Equip your regulatory affairs team with our eCTD submission software, boasting advanced dossier tracking features for seamless access to vital information and documentation, ensuring efficiency and compliance.
Compliance With Agency Standards
Ensure compliance with health authority requirements by utilizing pre-defined eCTD templates accepted by regulatory agencies with our eCTD submission tool.
Cost-saving Cloud Versions
Choose the cloud-based versions of the software to significantly reduce maintenance costs, saving valuable resources with our eCTD Publishing software.
Parallel Collaboration Between Users
Enable parallel working across multiple users, countries, applications, and locations, promoting efficient collaboration and productivity with our eCTD solutions.
Robust Cloud Security
Rest assured with a robust cloud version that implements data encryption and firewall security, providing a secure environment for your data with our eCTD system.
Automated Data Protection
Enjoy automatic live data backup and data disaster recovery features, ensuring the safety and integrity of your information with our eCTD viewer software.
Minimal IT Infrastructure
Benefit from the software’s minimal IT infrastructure requirements, saving time and resources during implementation with our eCTD validation software.
Secure Client-specific Storage
Maintain data confidentiality with separate encrypted databases and storage dedicated to each client, ensuring data security and privacy with our eCTD Publishing tool.
NextGen eCTD Features
Experience the NextGen eCTD Software
Experience the NextGen eCTD Software, the ultimate solution for seamless creation, management, compilation, publishing, review, validation, and archiving of fully compliant dossiers in eCTD format, adhering to the highest Regulatory (Regional and ICH) specifications.
Comprehensive Dashboard
Track scheduled and overall submissions efficiently using an effective dashboard. The live dashboard of NextGen eCTD tool provides users, admins, and management at different levels with a single-click report (in different formats like PDF, JPG, CSV, etc.) on activities such as total submissions, upcoming submissions, monthly submissions, and submission status.
Autocorrect Properties
NextGen eCTD submission software automatically corrects File Names and Leaf Properties by inheriting the Title, while also updating PDF properties such as Inherit Zoom, Fast Web View, and Conversion from PDF Version 1.4 to 1.7, ensuring compliance with country-specific requirements.
Application History Tracking (eCTD View)
By using NextGen eCTD solution, access the required standard views, including Sequential, Current, Cumulative, Consolidated, and Lifecycle View, with a single click. Multiple viewers can simultaneously access and view eCTD submissions using the software.
Seamless Inheritance of Regional/ICH Attributes
Ensure flawless life-cycle management of eCTD applications by automatically inheriting Regional envelope and ICH attributes elements from previous sequences using the NextGen eCTD tool.
Automated STF File Tag Element and Node Extension
Automate STF (Study Tagging File) creation for CSR (Clinical Study Report), Datasets, and CRF (Case Report Form) for US and Canada submissions. The NextGen eCTD tool also automates Node Extension for United States, Europe, United Kingdom, Canada, Gulf Council, Jordan, Australia, Switzerland, South Africa, Thailand, Singapore, and Taiwan submissions.
Incremental Publishing with Auto Synchronization
Handle last-minute changes in submissions by automating incremental publishing, allowing for updates only. The NextGen eCTD system ensures automatic document synchronization and checksum generation.
Legacy Submission Migration with Lifecycle Management
Easily migrate/import entire applications (including applications with multiple sequences) or single sequences using the automated Import functionality of NextGen eCTD Publishing tool, enabling a smooth transition and lifecycle management.
Country-Wise Flag Access and Specific Filters
Efficiently manage country-wise applications and their respective sequences using the NextGen eCTD software’s country-wise flag access. Proper filters are available to facilitate the completion of publishing tasks.
Country-Specific Auto eCTD Validator at Each Stage
Minimize errors by implemented country-specific auto eCTD Validation at various stages, including Regional/Envelop selection and filling, ICH Metadata, File Uploading, Compilation, and Publishing.
Dossier-Acknowledgment Repository with Email Notifications
Streamline communication with cross-functional teams by automating email notifications for successful eCTD submissions to Health Authorities. Maintain a repository for submission acknowledgments, ensuring efficient tracking and record-keeping. Built with Regulatory specifications, validation, and compliance, Masuu Global has robust and fully compliant NextGen eCTD software for pharmaceuticals, biopharmaceuticals, healthcare, and life-sciences industry throughout the globe and it’s fully compliant with Regional and ICH standards.
Built with Regulatory specifications, validation, and compliance.
Masuu Global has robust and fully compliant NextGen eCTD software for pharmaceuticals, biopharmaceuticals, healthcare and life-sciences industry through out the globe and its fully compliant with Regional and ICH standards.
USA (USFDA) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 2.5
- Regional DTD – V 3.3
- eCTD Validation Criteria – V 4.4
- ICH eCTD Specification – V 3.2.2
- ICH Study Tagging File (STF) – V 2.6.1
- Study Data Technical Conformance Guide – V 5.1
- Electronic Format Submissions, Revision 7 (Feb’20)
EU (EMA and EDQM) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 3.0.4
- Regional DTD – V 3.0.1
- eCTD Validation Criteria – V 7.1
- ICH eCTD Specification – V 3.2.2
UK (MHRA) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 3.0.4
- Regional DTD – V 3.0.1
- eCTD Validation Criteria – V 7.1
- ICH eCTD Specification – V 3.2.2
Canada (Health Canada) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 2.2
- eCTD Regional DTD – V 2.2
- eCTD Validation Criteria – V 5.1
- ICH eCTD Specification – V 3.2.2
- ICH Study Tagging File (STF) – V 2.6.1
GCC (Oman, Kuwait, Qatar, UAE, Saudi Arabia and Bahrain) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 1.5
- eCTD Regional DTD – V 1.1
- eCTD Validation Criteria – V 1.4
- ICH eCTD Specification – V 3.2.2
Jordan (JFDA) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 1.1
- eCTD Regional DTD – V 1.1
- eCTD Validation Criteria – V 1.1
- ICH eCTD Specification – V 3.2.2
Australia (TGA) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 3.1
- eCTD Regional DTD – V 3.1
- eCTD Validation Criteria – V 3.1
- ICH eCTD Specification – V 3.2.2
Switzerland (SwissMedic) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 1.5
- eCTD Regional DTD – V 1.5
- eCTD Validation Criteria – V 1.5
- ICH eCTD Specification – V 3.2.2
South Africa (SAHPRA) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 3.0
- eCTD Regional DTD – V 2.1
- eCTD Validation Criteria – V 2.1
- ICH eCTD Specification – V 3.2.2
Thailand (THAI FDA) and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 1.0
- eCTD Regional DTD – V 1.0
- eCTD Validation Criteria – V 1.0
- ICH eCTD Specification – V 3.2.2
Singapore and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V 1.0
- eCTD Regional DTD – V 1.0
- eCTD Validation Criteria – V 1.0
- ICH eCTD Specification – V 3.2.2
Taiwan and ICH Standards of eCTD Publishing
- eCTD Module 1 Specification – V R1.1
- eCTD Regional DTD – V 1.0
- eCTD Validation Criteria – V 1.0
- ICH eCTD Specification – V 3.2.2
Find the Best Value for Your eCTD Software with NextGen eCTD Plans
Compare pricing plans for NextGen eCTD Publishing software and choose the one that suits your regulatory submission needs and budget. Get the best value for your investment with our comprehensive features and compliance with Health Authorities and ICH standards.