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.

Technical Specification

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

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

Discover the advantages of using e-CTD Plus for your regulatory submissions.

Streamlined Submissions

Efficiently manage and submit regulatory documents.

Enhanced Compliance

Ensure adherence to regulatory standards and guidelines.

Improved Efficiency

Reduce time and effort in document preparation and submission.

Cost Savings

Lower costs associated with regulatory submissions.

User-Friendly Interface

Easy-to-use platform for all users.

Secure Data Management

Protect sensitive information with robust security features.

Real-Time Collaboration

Collaborate with team members in real-time.

Automated Workflows

Automate repetitive tasks to save time.

Comprehensive Reporting

Generate detailed reports for better insights.

Customizable Templates

Use templates tailored to your needs.

Regulatory Updates

Stay informed with the latest regulatory changes.

24/7 Support

Access round-the-clock support for any issues.