Capabilities
Purpose-built AI modules that integrate directly with India's regulatory infrastructure.
Automatically detects and masks PII and PHI in clinical trial data, ensuring full DPDP Act 2023 compliance across all submissions.
Converts high-volume regulatory filings and SAE narratives into concise, standardized summaries optimised for CDSCO review.
Flags missing fields, classifies case severity, and detects duplicates before submission to SUGAM and MD Online portals.
Domain-adapted Named Entity Recognition and Natural Language Processing tuned for legal and medical precision.
Foundation models fine-tuned on anonymised clinical trial documents, SUGAM templates, and CDSCO regulatory guidelines.
Architecture designed for replication across financial reporting, legal contract review, and public health surveillance.
Methodology
Every stage is engineered for legal and medical accuracy with rigorous validation.
Rigorous sanitisation and tokenisation of medical text with full audit trail.
Models trained on anonymised clinical trial documents and CDSCO regulatory templates.
Reinforcement learning with human feedback focused on legal accuracy over creative generation.
dMRV auditing architecture ensures ongoing solution enhancement and compliance validation.
Core Technologies
Our foundation models leverage massive proprietary scientific datasets, fine-tuned with supervised learning on CDSCO-specific regulatory content for unmatched contextual accuracy.
Domain-adapted NLP pipelines for medical & legal text
PII/PHI detection with 99%+ accuracy on clinical data
Fine-tuned for regulatory summarisation, not creative output
Human-in-the-loop feedback loops ensuring factual precision