Platform Capabilities

End-to-End Regulatory Intelligence

Three core AI modules purpose-built for India's pharmaceutical regulatory ecosystem — from data anonymisation to submission-ready compliance validation.

DPDP Act 2023 Compliant

Data Anonymisation Engine

Automatically detects and masks Personally Identifiable Information (PII) and Protected Health Information (PHI) across clinical trial datasets before submission to CDSCO portals.

99.4%
PII Detection Accuracy
< 2s
Per-Document Processing
47+
Entity Types Detected
12
Indian Languages Supported

PII Detection & Masking

  • Detects 47+ PII entity types including Aadhaar numbers, PAN cards, passport numbers, phone numbers, and email addresses
  • Contextual masking preserves data utility — replaces patient names with consistent pseudonyms across linked documents
  • Supports Hindi, Tamil, Telugu, Bengali, and 8 additional Indian language scripts for multilingual PII detection
  • Reversible tokenisation allows authorised personnel to de-anonymise with HSM-backed key management

PHI Redaction Engine

  • Identifies 23 PHI categories as defined under HIPAA and India's DPDP Act 2023 Section 4(2)
  • Clinical note parsing extracts and redacts diagnosis codes (ICD-10), treatment protocols, and lab values tied to identifiable patients
  • Image-based PHI detection for scanned consent forms using OCR + NER pipeline with 98.7% recall rate
  • Audit trail logs every redaction event with timestamp, entity type, confidence score, and operator ID

Compliance Certification

  • Automated compliance reports generated for each anonymisation batch with DPDP Act section-by-section mapping
  • Data Processing Impact Assessment (DPIA) templates auto-populated based on detected data categories
  • Consent management integration verifies patient consent status before processing begins
  • Quarterly compliance dashboards with trend analysis, violation alerts, and remediation tracking
SAE Narrative Processing

Automated Document Summarisation

Converts high-volume regulatory filings, clinical study reports, and Serious Adverse Event narratives into concise, standardised summaries optimised for CDSCO reviewer workflows.

96.2%
Factual Accuracy
85%
Time Reduction
50+
Document Types Supported
3,200+
CSRs Processed Monthly

SAE Narrative Summarisation

  • Processes CIOMS-I and MedWatch format SAE reports, extracting key causality assessments, patient demographics, and outcome data
  • Generates 150–300 word executive summaries from 10–50 page SAE narratives with 96.2% factual accuracy score
  • Automatic MedDRA coding — maps adverse events to Preferred Terms (PT) and System Organ Class (SOC) with human-in-the-loop verification
  • Temporal event extraction creates structured timelines of drug exposure, symptom onset, intervention, and outcome

Clinical Study Report (CSR) Analysis

  • Extracts efficacy endpoints, statistical significance data, and safety profiles from Phase I–IV CSR documents
  • Cross-references study findings against CDSCO's New Drug Application (NDA) requirements checklist — flags gaps in submitted data
  • Automated comparison of Indian CSR submissions against ICH-E6(R2) Good Clinical Practice guidelines
  • Generates regulator-ready summary tables for demographics, disposition, adverse events, and primary/secondary endpoints

Signal Detection Summaries

  • Aggregates individual case safety reports (ICSRs) to identify emerging safety signals across clinical trial populations
  • Disproportionality analysis using PRR, ROR, and EBGM algorithms with automated threshold alerting
  • Generates periodic safety update summaries aligned with PSUR/PBRER format requirements
  • Integration with VigiBase and India's PvPI (Pharmacovigilance Programme of India) adverse event databases
Pre-Submission Validation

Completeness Assessment

Validates regulatory submissions against SUGAM and MD Online portal requirements — flags missing fields, classifies case severity, detects duplicates, and ensures submission readiness.

340+
Fields Validated
99.1%
Duplicate Detection Rate
72%
Faster Pre-Submission QC
< 15min
Full Submission Audit

Field-Level Validation

  • Maps 340+ required fields across Form CT-04, Form 12, Form 44, and 28 additional CDSCO submission templates
  • Real-time validation as data is entered — highlights missing mandatory fields with contextual guidance on required format
  • Cross-field consistency checks: verifies dosage units match formulation type, date ranges are logical, and investigator credentials are current
  • Version-aware validation adapts to CDSCO template updates within 48 hours of official notification

Duplicate Detection & Deduplication

  • Fuzzy matching algorithm identifies potential duplicate submissions across patient identifiers, study sites, and adverse event descriptions
  • Configurable similarity thresholds: strict mode (>95% match) for regulatory submissions, relaxed mode (>80%) for literature screening
  • Cross-portal deduplication between SUGAM and MD Online identifies cases submitted to both systems inadvertently
  • Merge assistant suggests consolidated records with field-by-field comparison for manual review and approval

Severity Classification & Triage

  • Automated severity grading using CTCAE v5.0 criteria for adverse events — classifies Grade 1 (mild) through Grade 5 (death)
  • Expedited reporting flag automatically triggers for unexpected serious adverse reactions requiring 7/15-day CDSCO notification
  • Risk-based triage prioritises reviews by combining severity score, causality assessment, and drug class risk profile
  • Dashboard visualisation shows submission queue with colour-coded severity, deadline countdown, and assigned reviewer status

Advanced Capabilities

Underlying AI Infrastructure

Advanced NLP & NER

Domain-adapted Named Entity Recognition and Natural Language Processing pipelines tuned for legal and medical precision across Indian regulatory contexts.

  • Custom BioBERT model fine-tuned on 2.4M Indian clinical documents
  • Entity linking to SNOMED-CT, MedDRA, and ICD-10 ontologies
  • Relation extraction for drug-disease, drug-adverse event, and drug-drug interactions
  • Negation detection prevents false-positive entity extraction from clinical notes

Proprietary Training Data

Foundation models fine-tuned on anonymised clinical trial documents, SUGAM portal templates, and CDSCO regulatory guidelines.

  • Training corpus of 18M+ regulatory documents spanning 15 years of CDSCO filings
  • Continuous data pipeline ingests new CDSCO circulars, notifications, and template updates
  • Data provenance tracking ensures every training sample has documented source and consent status
  • Stratified validation sets ensure model performance across therapeutic areas and document types

Modular & Replicable Architecture

Designed for deployment across regulated industries requiring strict compliance automation.

  • Microservices architecture with independent scaling for each AI module
  • API-first design with OpenAPI 3.0 specifications for enterprise integration
  • Sector-specific model adapters for financial reporting (RBI), legal compliance (MCA), and public health (ICMR)
  • White-label deployment option for regulatory consultancies and CROs

Integrations

Connected to India's Regulatory Infrastructure

SUGAM Portal

Live

Direct API integration for drug & clinical trial applications

MD Online Portal

Live

Medical device registration and compliance submissions

PvPI Database

Live

Pharmacovigilance Programme of India adverse event reporting

VigiBase (WHO)

Beta

WHO global individual case safety report database

ICMR CTRI

Live

Clinical Trials Registry of India — trial registration validation

eCTD Gateway

Coming Soon

Electronic Common Technical Document submission pipeline

See ReguAI in Action

Schedule a personalised demo to see how our AI modules integrate with your regulatory workflow.