RoboReg is an AI‑driven Regulatory Information Management System that automates the creation, formatting, and submission of eCTD dossiers for Health Canada and the FDA. By extracting data with natural‑language processing, applying robotic process automation, and offering a cloud‑based collaborative workspace with API integrations, it reduces manual errors, ensures compliance, and speeds up drug approval timelines.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical companies managing drug registration in Canada rely on manual spreadsheets, email exchanges, and fragmented processes, leading to slow submissions, formatting errors, and version‑control issues that can cause regulatory delays or rejections.
Solution
RoboReg provides an AI‑driven Regulatory Information Management System that automates the creation and formatting of eCTD submission packages for Health Canada and the FDA. The platform extracts relevant data from source documents using natural‑language processing, populates required fields, and ensures compliance with the latest eCTD guidelines. Integrated APIs enable seamless data exchange with internal systems, while a cloud‑based workspace lets regulatory, clinical, legal, and quality teams collaborate in real time. Built‑in workflow controls and audit trails reduce human error, maintain version integrity, and accelerate the overall approval timeline.
Target Audience
Primary users are regulatory affairs, clinical, quality, and compliance teams within pharmaceutical companies developing new drugs for the Canadian market.
Features
- AI‑powered natural‑language processing that auto‑extracts and maps data from regulatory documents into eCTD fields
- Automated generation of compliant eCTD dossiers with Health Canada and FDA formatting standards
- Robotic Process Automation (RPA) for repetitive data entry, version control, and document assembly
- API integration layer for connecting to existing LIMS, QMS, and clinical data systems
- Cloud‑based collaborative workspace with role‑based access, real‑time editing, and audit logging
- Continuous updates to reflect evolving global regulatory guidelines and best practices