Validate, view, and compile eCTD submissions across 11+ regulatory authorities — free of charge during our testing phase. Write to us from your business email and we'll send you the download link directly.
Built for precision, speed, and reliability — without the enterprise price tag or the complexity.
Test against 11 regulatory authorities simultaneously — EU EMA, US FDA, Health Canada, PMDA Japan, ANVISA, TGA, and more from a single interface.
Export validation reports in TXT, CSV, HTML, and PDF. Clean, structured outputs ready to share with your team or attach to a client submission.
Navigate dossier structure with an intuitive tree view, track document lifecycle across sequences, and preview PDFs instantly — all in one window.
No installer, no configuration, no IT tickets. Download, run, and validate immediately. Works fully offline after first launch.
The Full edition runs on a robust database backend, maintaining consistent performance even with large dossiers and complex multi-sequence submissions.
The Full edition adds intelligent sequence creation wizards, letting you build new eCTD sequences from scratch while staying compliant at every step.
The name carries two meanings that reinforce each other — one from computer science, one from chemistry — and both are deliberate.
In computer science, an atomic operation either completes entirely or not at all — there is no half-written, corrupted in-between state. Every read, write, migration, and compilation in Atomic.eCTD is a single database transaction with this guarantee. If anything goes wrong, nothing is left broken. For regulatory submissions where data integrity is non-negotiable, this is the foundation everything else is built on.
In chemistry, the atom is the smallest unit that retains the identity of an element. An eCTD sequence is the same: the fundamental, indivisible unit of a regulatory submission — a complete, self-contained package that either exists as a valid whole or not at all. The orbital logo is not decorative; it is a precise metaphor for how the software handles your data.
The practical upshot: drafts are counted from the database, not scanned from the filesystem. All data lives in one backup location. Legacy files are migrated automatically and safely the first time they are accessed. The architecture is ready for versioning, sharing, and templates — because atomic transactions make all of that straightforward to build reliably.
Consistent workflow and a single licence across every region you operate in. No juggling separate tools.
eCTD v4 — the Regulated Product Submission format — is transforming how submissions are structured worldwide. Japan made it mandatory first. More authorities will follow.
Atomic.eCTD is built on a modern, maintainable architecture with an active development roadmap, so your tooling stays current with every regulatory change, automatically.
During our testing phase, the entire Atomic.eCTD program — viewer, validator, and compiler — is available at no charge. The only paid option is our IQ/OQ documentation and validated-environment package, designed for GMP-regulated facilities.
We are releasing the full Atomic.eCTD program — including the eCTD compiler — free of charge while we complete testing. Write to us from your business email and we will send you the download link. We welcome feedback from regulatory professionals who put the software through its paces.
The complete eCTD suite — viewer, validator, and compiler — fully functional, no restrictions. Write to us from your business email to receive the download link.
For pharmaceutical companies operating under GxP requirements who need formally qualified software in their regulated environment.
To receive the download link, simply write to us from your business email. We'll respond promptly with the link and any onboarding notes.
Write to us from your business email and we'll send you the download link, along with any onboarding notes. We also welcome feedback, technical questions, and enquiries about the IQ/OQ qualification package.
SGS Pharma Magyarország Kft.
Honvéd Utca 8. 1.em.2 · 1054 Budapest, Hungary