Optimized Workflow
Experience an effective workflow that reduces publishing time by 40%, enhancing overall efficiency.
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IntroducingNextGen eCTD 
software.
The ultimate solution for creating, managing, compiling, publishing, reviewing, validating, and archiving dossiers in fully compliant eCTD format, meeting the highest Regulatory (Regional and ICH) specifications.
Available For Cloud | Server
Nextgen eCTD Supporting Countries
KEY BENEFITS
Streamline & Enhance with NextGen eCTD
All-in-One Publishing Solution
Benefit from a comprehensive software solution that covers eCTD, NeeS, and pCTD publishing activities, simplifying your regulatory submissions.
Dossier Tracking
Facilitate health authority inspections by utilizing dossier tracking features, ensuring easy access to relevant information and documentation.
Compliance With Agency Standards
Ensure compliance with health authority requirements by utilizing pre-defined eCTD templates that are accepted by regulatory agencies.
Cost-saving Cloud Versions
Choose the cloud-based versions of the software to significantly reduce maintenance costs, saving valuable resources.
Parallel Collaboration
Enable parallel working across multiple users, countries, applications, and locations, promoting efficient collaboration and productivity.
Robust Cloud Security
Rest assured with a robust cloud version that implements data encryption and firewall security, providing a secure environment for your data.
Automated Data Protection
Enjoy automatic live data backup and data disaster recovery features, ensuring the safety and integrity of your information.
Minimal IT Infrastructure
Benefit from the software's minimal IT infrastructure requirements, saving time and resources during implementation.
Secure Client-specific Storage
Maintain data confidentiality with separate encrypted databases and storage dedicated to each client, ensuring data security and privacy.
NextGen eCTD Features
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.
FEATURE 01
Comprehensive Dashboard
Track scheduled and overall submissions efficiently using an effective dashboard. The live dashboard 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.
FEATURE 02
Autocorrect Properties
NextGen eCTD 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.
FEATURE 03
Application History Tracking (eCTD Viewer)
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.
FEATURE 04
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 software.
FEATURE 05
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 software also automates Node Extension for United States, Europe, United Kingdom, Canada, Gulf Council, Jordan, Australia, Switzerland, South Africa, Thailand, Singapore and Taiwan submissions.
FEATURE 06
Incremental Publishing with Auto Synchronization
Handle last-minute changes in submissions by automating incremental publishing, allowing for updates only. The software ensures automatic document synchronization and checksum generation.
FEATURE 07
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 software, enabling smooth transition and lifecycle management.
FEATURE 08
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.
FEATURE 09
Country-Specific Auto eValidation at Each Stage
Minimize errors by implementing country-specific auto eValidation at various stages, including Regional/Envelop selection and filling, ICH Metadata, File Uploading, Compilation, and Publishing.
FEATURE 10
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 through out the globe and its fully compliant with Regional and ICH standards.
USFDA and ICH Standards
USA (USFDA) 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
EU (EMA and EDQM) 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
UK (MHRA) 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
Canada (Health Canada) 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
GCC 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
Jordan (JFDA) 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
Australia (TGA) 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
Switzerland (SwissMedic) 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
South Africa (SAHPRA) 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
Thailand (THAI FDA) 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 (Singapore-FDA) and ICH standards
Singapore 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 (FDA) and ICH standards
Taiwan 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 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.
What Our
Client's Say
About Us.
Feedback
NextGen eCTD software has revolutionized our submission process. It's user-friendly interface and automated features have significantly reduced our workload, ensuring timely and accurate submissions.
Head - Regulatory Affairs
Pharma Formulation - India
We are highly impressed with the seamless integration and advanced functionality of NextGen eCTD software. It has greatly improved our document management and compliance with regulatory requirements.
VP - Regulatory Affairs
Pharma API - USA
NextGen eCTD software has been a game-changer for us. Its comprehensive tracking and reporting capabilities have made it easier to monitor our submission progress and stay on top of regulatory deadlines.
Director Regulatory Affairs
Pharma Formulation - India
We have found NextGen eCTD software to be extremely reliable and efficient. Its robust validation features have helped us avoid errors and ensure our submissions meet the highest regulatory standards.
Manager - Regulatory Affairs Pharma Drug Store - Jordan
NextGen eCTD software has greatly enhanced our collaboration and communication with cross-functional teams. Its intuitive interface and real-time updates have improved efficiency and productivity across our organization.
HOD - Global Regulatory Affairs Pharma Formulation - UAE
Experience the power of NextGen eCTD! Request a demo and discover how it can revolutionize your submission process.Request Demo