Automation has its impact on all industries and business functions today and making it’s mark aggressively every year. It’s making major impact in some areas with advanced methods (like AI and Machine Learning) while other areas are limited to simpler process automation with simpler methods (like RPA, BPM, Digitization).
DDi’s REGai™ is currently the TOP platform for automating several processes in Reg Affairs, Reg Ops, Regulatory Writing and CMC functions. Uniqueness to the platform is brought in by domain specific Ontologies built-in which helps companies leverage the knowledge in tool Day 1. From technology point of view, depending on the business function, it uses a combination of NLP (for reading from legacy pdf/word documents), NLG(for humanizing the text writing automatically) and BPM for workflows. Our Reg Intel database is integrated to provide real-time inputs into the strategy and change impact assessment. It also connects to other 3rd party systems like ERP, EDMS, RIM, EDC, SAS datasets, Change control, LIMS, and Excel files for effective data exchange.