The Art of Precision Publishing
In the current regulatory landscape, an eCTD submission is a critical milestone. A single validation error or broken hyperlink can result in a "Refusal to File," costing months of delay.
At RegOps, we view eCTD publishing as an art of precision. We don't just "format" your data—we architect your submission. We ensure every PDF is optimized, every XML backbone is robust, and every metadata tag is strategically aligned with regional Health Authority expectations. Whether it's an initial NDA or a complex variation, we provide a seamless bridge between your raw data and global regulatory approval.
Our Capabilities
End-to-end eCTD services from compilation to gateway submission.
Full compilation of Module 1-5 documents into validated eCTD sequences. We support INDs, NDAs, BLAs, MAAs, and all variation types across global markets.
Multi-tier validation against agency-specific requirements including PDF specs and granularity rules. We catch errors before agencies do to prevent technical rejections.
Direct electronic submission through FDA ESG, EMA CESP, Health Canada CESG, and other portals. We handle registration, ACK tracking, and troubleshooting.
Ongoing management of amendments, supplements, annual reports, and variations. We maintain sequence integrity and submission history across your portfolio.
Conversion of source documents to eCTD-ready format—PDF optimization, bookmarking, and hyperlinking. We ensure compliance with publishing standards.
Migration of paper-based archives or NeeS dossiers to full eCTD format for markets transitioning to mandatory electronic requirements.
The RegOps Advantage
We combine automated validation with specialist review to ensure first-time-right submissions.
First-Time-Right
Our multi-tier QC process catches issues before they reach the gateway. We don't submit until the sequence is clean.
Scalable Capacity
Whether you need support for a single submission or parallel filings across 20+ markets, we scale to match your requirements.
Software Agnostic
We work with your existing publishing tools or handle it entirely on our side, integrating into your workflows seamlessly.
Reg Intelligence
We monitor technical specification changes across agencies and proactively flag impacts so you know about new requirements early.