Regulatory Submission Operations
Outsourced eCTD publishing solutions that provide flawless execution, and require zero overhead investment
Developing the internal capabilities, infrastructure and expertise to prepare and publish quality electronic common technical documents (eCTDs) requires significant financial investment – dollars that are often better spent on research and innovation.
With comprehensive knowledge of eCTD publishing requirements and eCTD submission formats, our regulatory experts have submitted more than 150,000 eCTD files in the past four years, with zero technical rejections. If you’re looking for eCTD guidance, Smart Health India Regulatory Sciences has the experience you need in an outsourced regulatory publishing partner.
Customized solutions to fit your needs
We customize our approach to fit your organization – which means we can develop regulatory publishing deliverables in your systems, using your tools and processes. And, we can easily scale our work on a project, overflow or long-term engagement basis.
We’ve cultivated more than four decades of experience preparing, compiling, reviewing and publishing electronic drug listings, labeler code registrations, structured product labeling, drug establishment registration and generic drug firm self-identification (GDFSI) files. Let us put our scalable eCTD solutions to work for you.
Our eCTD experts have completed
- 130+ eCTD original submissions to FDA and global regulatory agencies
- 1,750+ lifecycle submissions to FDA and global regulatory agencies
- 160+ regulatory dossiers under maintenance and lifecycle management
- 10,000+ regulatory publishing deliverables for a single, global biopharmaceutical client
- 100+ clinical study reports (CSRs) published in eCTD/ICH E3 format
- 3,500+ electronic drug listing and establishment registration submissions
Learn how we can help you.
Learn how our outsourced eCTD publishing solutions ensure quality and eliminate your regulatory publishing overhead costs. Contact us today.