Features
What the product does today
Everything an ANDS submission needs, in one platform.
Four capabilities carry the work: reading your documents, generating Health Canada’s, checking the package against the rulebook, and telling you what is still missing. Everything else supports those four.
Reading the documents you already have.
Your dossier data already exists — in the product monograph, the master formulation record, the specification sheets. RoboReg reads them, extracts what the submission needs, and scores its own confidence on every field.
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Automatic document classification
Each upload is typed and mapped to its eCTD section.
Confidence scoring
High-confidence values approve in bulk; low ones get scrutiny.
Source traceability
Every value links back to the page it came from.
product_name
Metformin Hydrochloride ER Tablets
Product monograph, p. 1
proper_name
Metformin hydrochloride
Product monograph, p. 1
strength
500 mg
Product monograph, p. 3
dosage_form
Extended-release tablet
Product monograph, p. 3
excipients
7 entries in the formulation table
Master formulation record, p. 2
Confirmed data becomes Health Canada’s forms.
Cover Letter, Submission Certificate, Sponsor Attestation Checklist and the 3.2.P.2 narrative, generated from data your team has already confirmed — every field mapped in advance, every gap marked in the draft rather than guessed at.
Confirmed data becomes Health Canada’s forms.
Change a value later and RoboReg names the documents that went stale.
Missing-field highlighting
Unfilled fields are marked inline, with a hint about their source.
Change propagation
Regenerate in one click; hand-edited sections are preserved.
Rich document editor
Tables, change tracking, Word import and export.
Checked against the rulebook before you file.
The parts that must be exact — file naming, folder structure, index.xml, ca-regional.xml, MD5 checksums, PDF/A-1b rendering — are produced by deterministic code, then validated against Health Canada’s eCTD validation rules v5.3.
Only a package with zero blocking findings can be downloaded, and every download is recorded.
PDF/A verification
Compliance is checked by the pipeline, not assumed.
Plain-language findings
What is wrong, and what to do about it.
One-click packaging
A named, submission-ready ZIP.
1
Blocking
Nothing prevents this package from being filed.
2
Important
Bookmark missing on two generated PDFs.
5
Advisory
File names longer than the recommended length.
1
Blocking
Stops the filing. The workflow gate will not open.
2
Important
Should be resolved before you file.
9
Advisory
Improves the package without holding it up.
What’s missing, ranked by what stops a filing.
Your submission is scored against ANDS requirements every time you look, never from a cache. Blocking gaps hold the workflow gate shut. Important and advisory ones do not — so your team knows what to fix now and what can wait.
Each gap carries Health Canada guidance and a link straight to the screen that resolves it.
Missing documents and missing data
Both halves of “incomplete,” in one list.
Gaps become tasks
Assign one to a teammate in a single click.
Acknowledgements on record
Written reason, revocable, in the audit trail.
Architecture
Division of labour
AI reads. Deterministic code assembles.
The two halves of this product are built differently on purpose. A model is good at reading a monograph. It is the wrong tool for a checksum.
What the model does
- Classifies each uploaded document
- Maps it to its eCTD section
- Extracts the product data
- Scores its own confidence
What deterministic code does
- File naming and folder structure
- index.xml and ca-regional.xml
- MD5 checksums
- PDF/A-1b rendering
- Validation against HC rules v5.3
And the parts that make it usable in a team.
Workflow & collaboration
Four stages, each gated on the one before it, with the discussion kept next to the work.
- Approval gates on every stage
- Progress rail and stage history
- Threaded comments on documents
- Tasks with email notification
- Four roles, enforced server-side
Compliance, versioning & audit
A record of every change that nobody can edit afterwards — including us.
- Immutable audit trail
- Version history with restore
- Document locking while editing
- Help across 26 eCTD sections
Reporting
The state of every submission, in the room and on paper.
- Submission dashboard
- Four exportable PDF reports
- Validation run history
Administration & billing
Your subscription and your limits, managed by your own administrators.
- Self-service billing via Stripe
- Usage shown against tier limits
- Renewal and failure notices
