Automated pharmaceutical regulatory compliance tool
RoboReg is a Regulatory Information Management System (RIMS) powered by Artificial Intelligence (AI) for streamlining registration and submission for new drugs to regulatory authorities in Canada.
About Us
RoboReg is a Regulatory Information Management System (RIMS) powered by Artificial Intelligence (AI)
RoboReg is streamlining registration and submission for new drugs to regulatory authorities in Canada. The platform features Robotic Process Automation (RPA) for automated document filling. It is designed to conform to regulatory authorities’ electronic Common Technical Document (eCTD) standard. It allows collaboration among contributors of drug developments (pharmaceuticals, clinical research organizations, etc.) with its Application Programming Interface (API) integration capability. RoboReg delivers improved regulatory compliance, reduced errors, and improved efficiency. It utilizes AI to pull data from multiple sources and automatically populates a templatized, compliant document – without the need for manual entry. RoboReg addresses a widespread challenge among drug development and medical device companies with the enormous volume of regulatory documentation involved in new product submission to Health Canada and FDA in Canada.
The AI functionality analyzes documents from multiple sources and centralizes and optimizes data to be used efficiently RoboReg’s framework is developed based on industry best practices and regulatory requirements for pharmaceuticals, life sciences, and medical device companies.
- Analyze documents from multiple IT Systems
- Comparison of regulatory compliances
- Access to pre approved answers
Mission
RoboReg is operating as an AI-powered Regulatory. Information Management System for streamlining and accelerating registration and submission of new drugs by pharmaceutical and medical device companies to regulatory authorities Canada
Vision
Roboreg’s vision is to help Pharmaceutical and Medical. Device Manufacturers to launch new products within shortest possible time to save time, cost & lives.
FAQs
Roboreg is an automated healthcare dossier management tool that helps compile documents for regulatory submission.
Roboreg is an AI-powered platform that healthcare product manufacturers can use to analyze documents from multiple IT systems, centralizes and optimize the data to be used efficiently, and submit to the regulatory body.
Ready-to-use AI-powered Version for regulatory submission across the globe with the below features AI-powered is enabled to analyze the documents from multiple IT systems, centralizes and optimizes the data to be used more efficiently and accurately Minimum Server and Client Machine requirements as it is mostly a web-based application No specialized software or hardware is required.
Roboreg is designed to comply with all the requirements across the globe including USFDA, Health Canada, and EMA depending on the partner’s requirement country-specific modules could be provided. It is suitable for all types of dossiers for manufacturers of API, drug products, and medical devices. So it has versatile capabilities.
Roboreg’s web-based application will be updated regularly. A dedicated Regulatory compliance team will look after all up-to-date guidelines of concerned Partners will be noticed before such implementation. Patch updating, IQ, and PQ will perform accordingly as per requirements.
Roboreg has a strong belief in partnership rather than sales only. Partners’ success is the success of Roboreg. Roboreg will be connected to all its partners virtually and physically to get their success. A dedicated RSSM (Regulatory submission support manager) will assign to each client to ensure prompt response and support for any submission hurdle.
meet the team
The RoboReg Team
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