One connected platform for safety intake, case processing, aggregate reporting, signal management, the PSMF and quality. It's built for life-sciences teams who need speed without giving up control.
Trusted by life-sciences service leaders
Built around the standards your inspectors expect
Every Nirnāśā product works on its own and gets stronger together. Data captured at intake flows into cases, cases feed aggregate reports and signals, and quality underpins all of it.
Calls, emails, forms, PDFs, published literature and patient posts on social media all arrive in one intake queue. AI extracts the key fields, classifies each contact and flags seriousness before anyone opens the case.
Explore PV IntakeA guided workflow runs from book-in through data entry, coding, medical review and QA to submission. AI drafts the narrative and suggests MedDRA terms, while regulatory clocks track every 15- and 90-day deadline.
Explore ICSR SuiteSchedules, data lock points and due dates are generated automatically. Reports are authored from templates, move through quality, medical and client review, and export as e-signed DOCX and PDF versions.
Explore Aggregate ManagerPRR, ROR, IC and EBGM, plus TreeScan and sequential surveillance, run on FAERS and your other sources. Each signal gets a transparent priority score and moves through a GVP Module IX lifecycle with committee decisions and risk actions.
Explore Signal ManagementThe PSMF is generated from structured regulatory data rather than typed up by hand. Every change is traced to the sections it affects, routed for approval by risk, and can be reconstructed as it stood on any past date.
Explore PSMFDeviations, investigations, CAPA, change control, documents and training live in one agentic eQMS. AI drafts the root-cause analysis and suggests CAPA, and a person signs off every decision.
Explore QMSNot mock-ups: these are screens from the working platform your team would use every day.
Start with the module you need most today and add the rest as your pharmacovigilance operation grows.
MICC · Literature · Social media
AI extracts, classifies and checks every call, email, article and patient post before a case is opened.
End-to-end case processing
Book-in, coding, causality, medical review and QA in one guided workflow, with 15- and 90-day clocks tracked for you.
PADER · PSUR / PBRER · DSUR
Schedules, data lock points and due dates are generated for you, and reports move from drafting to e-signed export.
Detection & signal lifecycle
PRR, ROR, IC and EBGM on FAERS and your own data, with transparent priority scores and committee decisions.
Pharmacovigilance System Master File
Automate PSMF maintenance, change-impact tracking, QPPV oversight, evidence management and inspection preparation.
Agentic eQMS for pharmacovigilance
Manage deviations, CAPA, change control, complaints, audits, documents and GxP training in one connected quality environment.
AI voice agents on live calls
Live phone calls are transcribed, answered from your knowledge base and spoken back in natural voices, with every call logged.
Talk to a pharmacovigilance expert
Tell us about your case volumes, reporting obligations and current tools, and we'll map where Nirnāśā fits.
Nirnāśā is a Hyderabad-based AI company building enterprise platforms for life sciences, healthcare and regulated businesses. We handle the whole technology lifecycle: product strategy, solution architecture, development, integration, deployment and ongoing optimisation.
AI proposes and people decide, and every step is logged.
Audit trails, e-signatures and ALCOA+ from day one.
One source of truth across products.
Your workflows, roles and timelines, set without code.
Our models extract, classify, code and draft. Your experts review, override and sign. Every AI decision records the model, the prompt version, a confidence score and any human override.
Reporter, patient, product, dose, event and dates pulled from calls, emails, PDFs and scans.
Adverse event, medical inquiry, product complaint or non-case, with a consensus check across models.
Specialised agents detect signals, check the PSMF and draft investigations, with a human approving each result.
Case narratives, PSUR/PBRER sections and medical-inquiry replies drafted from your data.
A delivery approach shaped by validated-system practice, so your team goes live with confidence.
We map your safety processes, case volumes, partners and regulatory obligations.
Workflows, roles, forms, timelines and integrations are set up to match your SOPs.
Risk-based IQ/OQ/PQ documentation and a traceability matrix support your CSV approach.
We train your team, migrate your data and keep improving from real operating metrics.
Yes. Each product can be deployed on its own. Many teams start with PV Intake or the ICSR Suite and add Aggregate Manager, Signal Management, PSMF or QMS later. The data model is shared, so modules connect when you add them.
The platforms are designed around Part 11 and Annex 11 controls. They include append-only audit trails with user, time and reason; e-signatures that require re-authentication and a stated meaning; role-based access; and no hard deletes. Validation documentation (IQ/OQ/PQ, traceability) is available to support your computer system validation.
No. AI suggests extractions, classifications, codes, narratives and root causes. A qualified person reviews and approves every decision, and each AI output is logged with its model, confidence and any override.
The ICSR Suite generates ICH E2B(R3) XML, CIOMS I, MedWatch and PDF. It can also import E2B R2 and R3 files. Aggregate Manager authors PSUR, PBRER (ICH E2C(R2)) and DSUR (ICH E2F) documents and exports them as e-signed DOCX and PDF versions.
Nirnāśā runs as a cloud-native deployment, and the PSMF platform keeps each tenant in its own schema with data-residency controls. We'll agree the hosting region and model provider with your security and privacy teams during discovery.
See how Nirnāśā connects intake, cases, reports, the PSMF and quality in a 30-minute walkthrough tailored to your portfolio.
Our support team is available around the clock for all Nirnāśā services, so your safety operations never stop.
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