Optimized Workflow
Experience an effective workflow that reduces publishing time by 40%, enhancing overall efficiency.
Experience an effective workflow that reduces publishing time by 40%, enhancing overall efficiency.
Benefit from a comprehensive software solution that covers eCTD, NeeS, and pCTD publishing activities, simplifying your regulatory submissions.
Facilitate health authority inspections by utilizing dossier tracking features, ensuring easy access to relevant information and documentation.
Ensure compliance with health authority requirements by utilizing pre-defined eCTD templates that are accepted by regulatory agencies.
Choose the cloud-based versions of the software to significantly reduce maintenance costs, saving valuable resources.
Enable parallel working across multiple users, countries, applications, and locations, promoting efficient collaboration and productivity.
Rest assured with a robust cloud version that implements data encryption and firewall security, providing a secure environment for your data.
Enjoy automatic live data backup and data disaster recovery features, ensuring the safety and integrity of your information.
Benefit from the software's minimal IT infrastructure requirements, saving time and resources during implementation.
Maintain data confidentiality with separate encrypted databases and storage dedicated to each client, ensuring data security and privacy.
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.
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.
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.
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.
Ensure flawless life-cycle management of eCTD applications by automatically inheriting Regional envelope and ICH attributes elements from previous sequences using the NextGen software.
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.
Handle last-minute changes in submissions by automating incremental publishing, allowing for updates only. The software ensures automatic document synchronization and checksum generation.
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.
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.
Minimize errors by implementing country-specific auto eValidation at various stages, including Regional/Envelop selection and filling, ICH Metadata, File Uploading, Compilation, and Publishing.
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.
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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
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.
Experience the power of NextGen eCTD! Request a demo and discover how it can revolutionize your submission process.Request Demo