The questions a regulatory team actually asks.
Including the ones where the answer is no.
Does RoboReg submit to Health Canada for me?
No. RoboReg produces a validated, submission-ready eCTD package. You file it through Health Canada’s portal. Direct gateway submission is on our roadmap.
Which submission types are supported?
Abbreviated New Drug Submissions (ANDS) to Health Canada, in eCTD 3.2.2 Canadian format. Other submission types and regulatory authorities are on the roadmap.
Which parts of the dossier does RoboReg generate?
The eCTD XML backbone and folder structure, Module 1 supporting documents (Cover Letter, Submission Certificate, Sponsor Attestation Checklist), and Module 3.2.P.2 Pharmaceutical Development. Your other documents are uploaded, classified, and packaged into their correct eCTD locations. More Module 3 sections are coming.
Can the AI put a mistake in my submission?
Not without someone approving it. Extracted data is never used until a person confirms it field by field, and every autofilled value shows the source document behind it. The parts that must be exact are produced by deterministic code, not by a model.
Where does our data live, and who can see it?
In a database dedicated to your organization, designed to run in Canadian-region infrastructure. RoboReg administrators cannot view your submission or drug data and cannot impersonate your users. Every action is written to an audit log that can’t be edited.
What happens if our source data changes mid-submission?
RoboReg flags every affected document, names the exact fields that changed, and regenerates on request — preserving sections your team has already accepted or hand-edited.
How long does it take to get started?
Implementation covers consultation, configuration, template setup, and training. The product is designed so a new user can complete a guided onboarding walkthrough in under 30 minutes.
What's coming next?
More of Module 3 (2.3.P, then 3.2.P.1, P.3, P.5, P.8), more submission types (NDS, medical device licences, clinical trial applications), FDA and EMA support, direct gateway submission, and API access for CROs and partner labs.