REGai automates creation of Annual reports (by deriving required data directly from Sponsor's change control systems, ERP and RIM details) for FDA and minor variations for Europe. These include both CMC and Labeling.
As CMC content is mostly documents driven, CMCai, as part of REGai, automates data extraction from several formats including legacy and CTD dossiers, individual Substance & Product documents and non-CTD format files to generate the required data points as recommended. Documents accessible in different platforms/tools, data available from various sources & different document formats like PDF, e-mails and scanned documents can also be processed. Identification of CMC regulatory gap analysis, managing and providing effective CMC mitigation strategies. Provides all regulatory affairs stakeholders a holistic view of the entire CMC data to documents in the life cycle.