eCTD Services

We simplify your journey to global compliance with end-to-end eCTD (Electronic Common Technical Document) services. Whether you're submitting to the USFDA, EMA, Health Canada, or GCC authorities, our team ensures fully validated, technically sound submissions—on time, every time.

What We Offer:

1. eCTD Dossier Preparation & Compilation

• Module 1 customization as per country requirements

• Formatting and structuring of Modules 2–5

• Ready for initial submission, variation, and renewal

2. eCTD Publishing & Validation

• Fully compliant with regional eCTD specifications

• Validation reports

• Error-free submission through your preferred gateway or via local agent

3. Lifecycle Management

• Handling sequence updates for variations, responses, renewals

• Consistent control over dossier versioning

• Archived and auditable eCTD records

4. Gap Analysis & Legacy Conversion

• Transition paper/NeeS dossiers into eCTD format

• Identify and fix technical and regulatory inconsistencies

• Customized strategy for each authority’s expectations

5. Country-Specific Expertise

• USFDA, EMA, MHRA, TGA, Health Canada

• GCC (Saudi Arabia, UAE, Oman, Kuwait)

• ASEAN, LATAM, and CIS region eCTD models

Why Choose RGInsight?

• Successful submissions in multiple ICH and non-ICH markets

• Real-time coordination with regulatory teams

• Fast turnaround for urgent submissions

• Post-submission tracking and follow-up