Pharmacovigilance & Regulatory Compliance Software for Drug Safety Teams

Nirnāśa builds AI-driven tools for ICSR processing, MedDRA coding, and signal detection — helping pharma, biotech, and CRO teams stay audit-ready and inspection-compliant.

E2B(R3) compliant

ICSR data standard

ICH E2E aligned

Signal detection framework

50% faster

ICSR processing vs manual

100% audit trail

Every action logged

Who We Serve

We partner with organizations across industries to accelerate digital transformation and unlock enterprise value. Our AI-driven IT services are tailored to meet the unique needs of diverse sectors.

Healthcare & Life Sciences

Revenue cycle & operational intelligence for healthcare systems and hospitals. Drug discovery, safety & regulatory systems for pharmaceutical companies. AI governance & compliance platforms for enterprise organizations.

Pharmacovigilance & Drug Safety Teams

End-to-end PV software for ICSR intake, MedDRA coding, periodic safety reporting (PADER, PSUR, PBRER), and signal detection — built for pharma companies, CROs, and biotech startups with regulatory obligations.

pharmacovigilance CRO software · drug safety for biotech · PADER PSUR software · ICH E2B compliance tool · MedDRA coding software

Financial Services

Intelligent automation for banking and insurance. Fraud detection and risk management with AI. Digital platforms for customer experience.

Retail & Commerce

Personalized customer engagement powered by AI. Inventory and supply chain optimization. Omnichannel digital commerce solutions.

Pharmacovigilance Tools Built for Regulated Environments

Purpose-built software for drug safety teams that need speed, traceability, and inspection-readiness — without the complexity of enterprise legacy systems.

MICC — MedDRA Intelligent Case Coder

Structured MedDRA coding workflow with version control, case linkage, and audit-ready output. Supports MedDRA hierarchy (LLT → PT → HLT → SOC) with intelligent suggestions.

Best for: Drug safety associates, medical coders, PV managers

MedDRA coding tool · ICSR case coding · drug safety coding software

ICSR Aggregator — Multi-Source Case Management

Consolidates individual case safety reports from multiple sources (clinical trials, spontaneous, literature) into a single E2B(R3)-aligned view. Reduces duplicate effort and submission errors.

Best for: PV teams managing multiple products or client portfolios

ICSR management software · E2B R3 reporting tool · adverse event reporting system India

Signal Detection Aggregator Calendar

Schedule, track, and document periodic safety reviews — PADER, SIGNAL, PSUR, PBRER — with timestamped audit trails. Never miss a review deadline or fail an inspection on process gaps.

Best for: PV heads, regulatory leads, QA teams

signal detection software · PADER PSUR calendar · periodic safety review tool · pharmacovigilance scheduling

Our Product Suite

We empower healthcare and life sciences organizations with intelligent, outcome-focused solutions. Our AI-driven product suite is designed to accelerate innovation, improve patient outcomes, and streamline operations across the industry.

AegisRCM™

AI-Governed Enterprise Revenue Intelligence

Comprehensive revenue cycle management platform powered by advanced AI. Optimize coding, prevent denials, and maximize revenue.

AI-Powered Medical Coding

Autonomous coding with intelligent validation, reducing errors and improving accuracy.

Denial Prevention

Predictive denial risk analysis before claims submission to maximize acceptance rates.

Claims Processing

Automated claims scrubbing, validation, and prioritization with intelligent workflows.

Revenue Forecasting

Advanced analytics and cash flow forecasting with real-time KPIs and insights.

Payment Intelligence

Automated underpayment detection and recovery to maximize revenue collection.

Executive Dashboards

Real-time executive dashboards with actionable KPIs and role-based views.

HelixAI™

AI-Driven Drug Discovery Engine

Revolutionary AI platform accelerating drug discovery through advanced machine learning and molecular design.

Molecular Design

AI-powered molecular design and optimization for novel drug candidates.

Target Identification

Advanced algorithms for drug target identification and validation.

Predictive ADMET

AI-driven prediction of Absorption, Distribution, Metabolism, Excretion, and Toxicity.

Compound Screening

Intelligent virtual screening of compound libraries to identify promising candidates.

Lead Optimization

Data-driven lead optimization using machine learning models.

Drug Repurposing

AI-powered drug repurposing analysis for new therapeutic applications.

RegulusTX™

Product Data & Regulatory Intelligence

Comprehensive platform for managing product data, regulatory submissions, and compliance intelligence.

Pharmacovigilance Module

Integrated ICSR intake, signal management, and periodic reporting aligned to EMA, FDA, and CDSCO requirements. Supports IND, NDA, and MAA submissions with PV-specific data modules.

eCTD submission software · NDA pharmacovigilance · CDSCO drug safety compliance · EMA signal management tool

Submission Management

End-to-end management of regulatory submissions including eCTD, NDA, ANDA filings.

Product Data Management

Centralized product data repository with version control and data integrity controls.

Global Intelligence

Real-time monitoring of global regulatory changes across FDA, EMA, PMDA agencies.

Compliance Tracking

Automated compliance tracking and reporting for regulatory requirements.

Labeling Management

Intelligent labeling management with multi-country support and version control.

Lifecycle Management

Comprehensive product lifecycle management from development to post-market.

Strategy-to-execution services aligned to enterprise outcomes

we bridge the gap between vision and reality. Our consulting and IT services are designed to help enterprises move seamlessly from strategic planning to execution, ensuring measurable business outcomes.

Pharmacovigilance System Setup & Validation

End-to-end PV system implementation — from ICSR workflow design to signal detection SOP creation. Includes IQ/OQ/PQ validation documentation for GxP compliance. Ideal for companies preparing for their first regulatory inspection.

pharmacovigilance system validation · GxP compliance India · PV system implementation · drug safety SOP development

AI Strategy & Advisory

Enterprise AI roadmaps & governance frameworks for strategic implementation.

Implementation & Integration

EHR, ERP, LIMS & safety platforms integration with seamless deployment.

Managed Services

24/7 AI operations & optimization with proactive monitoring and support.

Regulatory Readiness

Inspection-ready systems & audits with comprehensive compliance support.

About Nirnāśa

Nirnāśa builds AI-assisted pharmacovigilance and regulatory software for drug safety teams worldwide. We focus on inspection-readiness: traceable workflows, aligned reporting, and tools that match how PV, medical, and QA groups actually work — without the weight of legacy enterprise stacks.

Founded with a validation-minded engineering culture, we partner with pharma, biotech, and CROs to shorten time-to-compliance and stand behind our products with direct, responsive support.

Book a Free 20-Minute Demo

See MICC, ICSR Aggregator, and Signal Detection Calendar running live on sample data. No slides. No commitment.