What is e-CTD Plus?

The Common Technical Document (CTD) is a standardised format for regulatory submissions, established by the International Council for Harmonisation (ICH) and accepted by regulatory agencies in Europe, Japan, and the United States. The electronic version, known as the electronic Common Technical Document (eCTD), ensures more efficient and compliant submissions by integrating two key components: content specification defined by ICH standards, and technical specification supported by advanced electronic software. e-CTD Plus simplifies the submission process, enabling faster and more efficient dossier preparation for regulatory approvals.

Technical Specification

Supported by advanced electronic software. e-CTD Plus simplifies the submission process, enabling faster and more efficient dossier preparation for regulatory approvals.

Content Specification

Defined by ICH standards.

Features of e-CTD Plus

Compliance Made Easy

All file names and titles adhere to regulatory standards.
Flexible Document Preparation

Create CTD documents directly in Word, with an option to import Word files. Attach CTD documents as optimised PDF files.
Template Integration

Include relevant guidelines or templates directly at the leaf level.
Defined Workflows

Assign roles for “Doer,” “Reviewer,” and “Publisher” to streamline tasks.

Comprehensive Reporting

Generate and view multiple reports, including audit trails.
Automated PDF Optimisation

Complies with agency requirements and includes built-in hyperlinking tools.
Technical Validation

Validates submissions based on the latest criteria set by regulatory authorities.
SPT Tool

Helps ensure submissions meet technical and content standards.

Modules of e-CTD Plus

Simplifying the regulatory submission process with powerful tools and seamless workflows

CTD Summaries (QOS)
Non-Clinical Study Reports
Administrative Information (Region Specific)
Quality (CMC)
Clinical Study Reports
Regulatory Correspondence

Benefits of e-CTD Plus

Simplifying the regulatory submission process with powerful tools and seamless workflows

Streamlined Submissions

Efficiently manage and submit regulatory documents.
Improved Efficiency

Reduce time and effort in document preparation and submission.
User-Friendly Interface

Easy-to-use platform for all users.
Real-Time Collaboration

Collaborate with team members in real-time.
Comprehensive Reporting

Generate detailed reports for better insights.
Regulatory Updates

Stay informed with the latest regulatory changes.
Enhanced Compliance

Ensure adherence to regulatory standards and guidelines.
Cost Savings

Lower costs associated with regulatory submissions.
Secure Data Management

Protect sensitive information with robust security features.
Automated Workflows

Automate repetitive tasks to save time.
Customizable Templates

Use templates tailored to your needs.
24/7 Support

Access round-the-clock support for any issues.

e-CTD Plus – Smarter Regulatory Submissions

What is e-CTD Plus?

Technical Specification

Content Specification

Features of e-CTD Plus

Compliance Made Easy

Flexible Document Preparation

Template Integration

Defined Workflows

Comprehensive Reporting

Automated PDF Optimisation

Technical Validation

SPT Tool

Modules of e-CTD Plus

Simplifying the regulatory submission process with powerful tools and seamless workflows

Benefits of e-CTD Plus

Simplifying the regulatory submission process with powerful tools and seamless workflows

Streamlined Submissions

Improved Efficiency

User-Friendly Interface

Real-Time Collaboration

Comprehensive Reporting

Regulatory Updates

Enhanced Compliance

Cost Savings

Secure Data Management

Automated Workflows

Customizable Templates

24/7 Support