M A S U U

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

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 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

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.

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.

Basic
Annual Subscription
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  • 1 User
  • 1 Region
  • Application Migration: ≤ 5
Business
Annual Subscription
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  • 2+ Users
  • 3 Regions
  • Application Migration: ≤ 25
Essential
Annual Subscription
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  • 5+ Users
  • All Available Regions
  • Application Migration: Unlimited

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