RoboReg
Regulatory submissions, assembled by AI.
Regulatory submissions, assembled by AI.
Approved by you.
RoboReg turns your source documents into a validated, Health Canada-compliant eCTD package. AI extracts the data. Your team confirms it. RoboReg builds, checks, and packages the rest.
The problem
Preparing an ANDS submission shouldn’t take a consulting firm.
Assembling a dossier means reconciling guidance documents, retyping the same product data into form after form, and building a folder structure with exacting rules for file naming, PDF specification, XML backbones, and checksums.
Assembling a dossier means reconciling guidance documents, retyping the same product data into form after form, and building a folder structure with exacting rules for file naming, PDF specification, XML backbones, and checksums.
Get any of it wrong and the submission comes back.
It’s slow and unforgiving enough that most companies hand the whole thing to a consultancy
— and pay for it every year.
Health Canada guidance documents govern how a drug submission is prepared.
Health Canada guidance documents govern how a drug submission is prepared.
Health Canada guidance documents govern how a drug submission is prepared.
Extraction review
Cover letter
Submission certificate
Sponsor attestation
3.2.P.2 Pharmaceutical Development
The strength changed this morning. RoboReg flagged the one document that depends on it
The solution
RoboReg brings submission preparation back in-house.
Upload your source documents. RoboReg classifies each one, maps it to its eCTD section, and extracts the product data inside it — with a confidence score on every field.
Your specialist confirms that data once. From there, RoboReg populates Health Canada’s Module 1 forms and your Module 3.2.P.2 narrative, renders PDF/A, builds the eCTD folder structure and XML backbone, validates the package against Health Canada’s rules, and hands you a submission-ready ZIP.
Change a source value later and RoboReg tells you exactly which generated documents went stale — and which fields changed.
How it works
From source documents to a filed submission, in five stages
Drop in your source documents. RoboReg identifies what each one is, suggests its eCTD section, and files it into the structure.
AI pulls out the data the dossier needs, each with a confidence score. Your specialist accepts, edits, or rejects — field by field or in bulk.
Confirmed data populates Module 1 forms and your 3.2.P.2 narrative. Anything missing is highlighted in the draft. Edit inline, or export to Word.
RoboReg renders PDF/A, builds the folder structure, index.xml and ca-regional.xml backbones and MD5 checksums — then validates against Health Canada’s rules.
Download a submission-ready ZIP and file it with Health Canada through their portal.
Why RoboReg
Built around the regulator you actually file with.
Every major RIMS platform is US-built for FDA requirements. RoboReg is built around Health Canada’s Canadian Module 1, ANDS requirements, and eCTD validation rules v5.3.
Canadian Module 1
ANDS
eCTD 3.2.2
Validation rules v5.3
AI handles what it’s good at — reading documents and extracting meaning. The parts that must be exact — file naming, folder structure, XML, checksums — are produced by code, never by a model.
AI handles what it’s good at — reading documents and extracting meaning. The parts that must be exact — file naming, folder structure, XML, checksums — are produced by code, never by a model.
From CAD $925/month, your team owns the process — instead of paying a consultancy for it every year.
RoboReg is in pilot. Early customers get implementation support and direct input into the roadmap.
The RoboReg team
The RoboReg team is a group of experts in pharma, AI, and compliance, dedicated to transforming regulatory workflows.
Sudhir Chandra Biswas
Chief Executive Officer
Md Mahbub Aleem
Chief Operating Officer
Mohammad Mahmudul
Technical Advisor
Muhammad Kader
Overseas Advisor
See it on your
own submission.
Book a 30-minute demo with a regulatory specialist. Bring a real ANDS document set and we’ll show you what RoboReg extracts from it.
- No procurement conversation required to see the product.
- A regulatory specialist is on the call, not just a salesperson.
- Your documents stay yours — nothing is retained after the demo.