Tell us about your product, market, and timeline — our specialists will design a testing programme that fits.
Our scientific team will help you identify the right tests, methods, and accreditations for your product or sample.
End-to-end drug safety services for Marketing Authorization Holders across India and global markets. Purpose-built to meet CDSCO circular mandates and IPC PV Guidance Version 2.0.
20+
Years of Experience
13
PV Services
100%
CDSCO Compliant
Global
Submission Capability
CDSCO Circular — June 2026: All Marketing Authorization Holders are now legally required to establish an effective Pharmacovigilance system. Auriga Research is ready to support your compliance journey.
About Our PV Services
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. In India, the Central Drugs Standard Control Organisation (CDSCO) mandates all Marketing Authorization Holders — manufacturers, marketers, and importers of licensed drugs — to maintain an active, audit-ready PV system.
Auriga Research Pvt. Ltd. is a CDSCO-registered Contract Research Organisation (CRO) with over 20 years of experience. Our pharmacovigilance team handles everything from initial system setup to ongoing safety monitoring, ICSR submissions, aggregate report writing, and independent audits — so you remain compliant without building an in-house team.
What We Do
Cloud-based, regulatory-compliant safety database for drugs, vaccines, devices & Ayush products.
Learn more →Complete setup, maintenance, and regulatory upkeep of your Pharmacovigilance Master File.
Learn more →End-to-end intake, MedDRA coding, medical review, and E2B(R3) electronic submission of Individual Case Safety Reports.
Learn more →PSUR, PBRER, DSUR and PADER writing aligned with ICH E2C(R2), E2F and NDCT Rules 2019.
Learn more →Statistical and qualitative signal detection, assessment and regulatory reporting.
Learn more →EU-RMP and US REMS preparation, submission support and lifecycle management.
Learn more →Role-specific PV training and SOP drafting for your team, with DMS integration.
Learn more →India and global PV regulatory framework — CDSCO, NDCT Rules 2019, ICH, EMA GVP and WHO guidance.
Learn more →Why Auriga
Your PV system goes live quickly from SLA signing — structured onboarding with no lengthy delays.
In-depth knowledge of CDSCO requirements, IPC PV Guidance V2.0, ICH guidelines, GVP Modules, and NDCT Rules 2019.
Direct E2B(R3) XML submissions to EMA, US FDA, and MHRA from a single platform.
AI-assisted case narrative generation, signal detection analytics, and automated compliance checks.
SOP development, team training and a Document Management System ensure your staff is always audit-ready.
13 PV services under one roof — from first ICSR to annual aggregate report to independent audit.
Common Questions
Contact our PV team for a free 30-minute consultation or a live demonstration of the Auriga Safety System.
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