Regulatory & Automation

Regulatory Automation

REGai automates several processes in Reg Affairs, Reg Ops and CMC functions. Some examples include 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, REGai automates data extraction from several formats including legacy and CTD dossiers, individual Substance & Product documents and non-CTD format files as recommended. REGai using AI, identifies the regulatory gaps, manages, controls and provides effective mitigation strategies. Provides all regulatory affairs stakeholders a holistic view of the entire data of the documents, in the life cycle.

Some projects we delivered to clients:

1. Compile dossiers from prev docs (using NLP) and cross checking Change Control / QA and RIM systems for updated data

2. Drug Master File (DMF) & New Drug Registrations (NDA/MAA) build automation

3. Build Annual Reports, Amendments, Post Approval Changes, Variations

4. Auto QC of eCTD and non-eCTD of ROW countries dossiers without manual intervention

5. CMC data extraction using NLP (and cmc business rules)

REGai Automation processes

  • Required Data available in Unstructured Format
  • Data available from various sources and different document formats like PDF, E-mails/Scanned documents
  • Need of one source of information to meet the scheduled Regulatory Submission timelines
  • Documents available in different Platforms / Tools
  • Lot of Manual effort
  • Resource Scarcity (even if available its very expensive)
  • Accessibility of Confidential Documents to all stakeholders

REGai enables companies to increase productivity and provide competitive advantage multiple times faster than any other technology. Artificial Intelligence and Machine Learning accelerate knowledge discovery to provide a holistic view of the information and data that enterprises would use more effectively & efficiently with low man power in short span of time.

Have Questions? Need Info/Quotes?


Have Questions? Need Info/Quotes?