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The connected platform for drug safety & quality

Seven purpose-built products covering the whole pharmacovigilance lifecycle, from the first adverse-event report to the master file your inspectors review.

AI triage

PV Intake

MICC · Literature · Social media

Capture every adverse event, from every channel.

AI extracts, classifies and checks every call, email, article and patient post before a case is opened.

MICC Literature Social media De-duplication
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E2B(R3) ready

ICSR Suite

End-to-end case processing

Process cases faster, with a full audit trail.

Book-in, coding, causality, medical review and QA in one guided workflow, with 15- and 90-day clocks tracked for you.

MedDRA coding Causality Medical review E2B(R3)
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ICH E2C(R2)

Aggregate Manager

PADER · PSUR / PBRER · DSUR

Never miss a periodic report deadline.

Schedules, data lock points and due dates are generated for you, and reports move from drafting to e-signed export.

Scheduling Authoring Review stages e-Signed exports
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GVP Module IX

Signal Management

Detection & signal lifecycle

Find the signal before it finds you.

PRR, ROR, IC and EBGM on FAERS and your own data, with transparent priority scores and committee decisions.

PRR / ROR EBGM FAERS Committee
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GVP Module II

PSMF Intelligence

Pharmacovigilance System Master File

Keep your PSMF inspection-ready, continuously.

Automate PSMF maintenance, change-impact tracking, QPPV oversight, evidence management and inspection preparation.

GVP Module II QPPV oversight Inspection ready
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21 CFR Part 11

Quality Management System

Agentic eQMS for pharmacovigilance

Turn quality operations into intelligent workflows.

Manage deviations, CAPA, change control, complaints, audits, documents and GxP training in one connected quality environment.

CAPA Deviations Change control Training
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Realtime

Voice Connector

AI voice agents on live calls

Answer calls with AI grounded in your documents.

Live phone calls are transcribed, answered from your knowledge base and spoken back in natural voices, with every call logged.

Telephony Your documents Language detection Transcripts
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30-minute walkthrough

Not sure where to start?

Talk to a pharmacovigilance expert

Build the right platform for your safety operation.

Tell us about your case volumes, reporting obligations and current tools, and we'll map where Nirnāśā fits.

  • Demo tailored to your products and markets
  • See it working on anonymised sample data
  • Start with one module and add more later
  • 24/7 on-call technical support after go-live
Across the platform

Shared foundations in every product

Human-governed AI

AI proposes and people decide. Model, confidence and overrides are logged for every suggestion.

Audit trail everywhere

Append-only, timestamped history of every create, change, approval and export.

Part 11 e-signatures

Re-authentication, a stated meaning and a reason on every controlled action.

Role-based access

Granular roles for processors, reviewers, QA, QPPV, auditors and administrators.

Configurable workflows

Timelines, forms, codelists and routing adapted to your SOPs, without custom code.

Cloud-native & secure

A modern stack (Python/FastAPI, PostgreSQL, React) deployed in the cloud region you choose.

AI agents coordinated by an orchestrator, with a human approving the outcome
AI inside every service

Generative and agentic AI, governed by your experts

Extraction, coding, signal triage, report drafting and investigations are all AI-assisted, and every decision is reviewed, signed and logged.

Beyond pharmacovigilance

More from Nirnāśā

Voice Agent

Multilingual voice AI agents for real-time conversations, intelligent call routing, transcription, workflow automation and hand-off to a person.

Business Suite

Invoicing, payment reconciliation, document management, agreement tracking, digital signing, approvals and business reporting.

Digital Platforms

Custom AI, web, mobile, cloud, API, analytics, RAG and multi-agent solutions for enterprise-scale needs.

Find the right starting point

Tell us about your portfolio and obligations, and we'll recommend the modules that deliver value first.

Support available now

24/7 on-call technical support for every service

Our support team is available around the clock for all Nirnāśā services, so your safety operations never stop.

  • PV Intake
  • ICSR Suite
  • Aggregate Manager
  • Signal Management
  • PSMF
  • QMS
  • Voice Connector