eCTD Services

Streamlining Regulatory Submissions with Global eCTD Compliance

In the pharmaceutical and life sciences industry, regulatory submissions must be accurate, structured, and compliant with global standards. Our eCTD Services (Electronic Common Technical Document) help organizations efficiently prepare, manage, and submit regulatory dossiers to health authorities worldwide.

The eCTD is a globally accepted standard format for submitting regulatory information such as applications, amendments, and reports to authorities like FDA and EMA. (Pharmuni)

We ensure your submissions meet all technical, regulatory, and compliance requirements—reducing delays and accelerating approvals.

What is eCTD?

The Electronic Common Technical Document (eCTD) is the digital version of the Common Technical Document used for drug approvals across global regulatory agencies.

It consists of 5 structured modules:

Module 1 – Regional Administrative Information
Module 2 – Summaries
Module 3 – Quality (CMC)
Module 4 – Non-Clinical Reports
Module 5 – Clinical Study Reports

eCTD uses structured electronic files (PDF + XML backbone) to organize and link documents for efficient review and lifecycle management. (Freyr Solutions)

Our eCTD Service Offerings

eCTD Publishing

Compilation, formatting, and structuring of documents as per global regulatory standards.

Validation Services

Technical validation to ensure submissions meet FDA, EMA, and other regulatory requirements.

Submission Management

End-to-end handling of dossier submissions, sequences, and lifecycle tracking.

Gap Analysis & Consulting

Identify compliance gaps and optimize your submission strategy.

Lifecycle Management

Manage updates, variations, amendments, and post-approval submissions.

Conversion Services

Convert paper or NeeS/CTD formats into fully compliant eCTD submissions.

eCTD solutions help companies prepare, compile, validate, and manage submissions in compliance with regulatory standards. (eCTD/CTD/NeeS Publishing solution)