Regulatory & Automation
AUTOMATION

Regulatory Automation

While AI is evolving in Regulatory areas, the true machine learning aspects will take time where data volume is still not large enough (except for areas like Regulatory Intelligence). MakroCare successfully applied this to a few areas where text and documents are heavily involved. Coming to Automation, We Successfully adapted to several functions and processes.

REGai is our proprietary platform that automates several processes in Reg Affairs, Reg Ops, Regulatory Writing and CMC functions. This platform uses a combination of domain-specific functional knowledge, business rules, NLP, NLG and BPM for effective workflows. IT also connects to other 3rd party systems like SAP, RIM, Document management systems, Change Control, and LIMS.

While several pilots are ongoing, some of the below projects delivered successfully to clients where they are gaining higher efficiency and productivity currently:

  • Compile dossiers from previous docs (using NLP) and cross-checking Change Control/QA and RIM systems for updated data
  • Stability and 2.1.P.8 automation from LIMS
  • Drug Master File (DMF) & New Drug Registrations (NDA/MAA) build automation
  • Build Annual Reports, Amendments, Post Approval Changes, Variations (by also integrating with RIM or Change control systems)
  • Health Authority responses centralization (starting with digitizing past responses and reuse past content with smart searches)
  • CMC data extraction using NLP (and CMC business rules) form documents
  • Labeling Automation from core to local eliminating manual QC

REGai Automation Benefits

  • 20-50% efficiency gains
  • Reduce manual efforts drastically
  • Less dependency on outsourcing or offshore resourcing
  • Run in cloud if you prefer and hence less IT footprint

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