Electronic Submission

Electronic Submissions

Our team has extensive expertise in the electronic Common Technical Document (eCTD) format—the globally accepted standard for regulatory submissions in the pharmaceutical and biotechnology industries. We offer end-to-end support for preparing, organizing, and validating your eCTD submissions to ensure they meet ICH guidelines and the specific requirements of agencies like the FDA, EMA, and other regulatory bodies.

Efficient Workflow & Timely Submissions:

By leveraging automated tools and industry best practices, we streamline the preparation process, reducing manual errors and accelerating review timelines.

Training & Consultation:

We also provide guidance on best practices and training for internal teams to maintain eCTD readiness for future submissions.