ICH E2 Compliant · PvPI Aligned

Pharmacovigilance Services India | Drug Safety Monitoring CRO

Auriga Research provides comprehensive pharmacovigilance services for pharmaceutical, nutraceutical, and cosmetic companies operating in India. Our drug safety monitoring capabilities cover the entire product lifecycle — from clinical trial safety reporting through post-marketing surveillance and ongoing benefit-risk assessment.

Our pharmacovigilance operations are aligned with ICH E2A/E2B/E2C/E2D/E2E guidelines, CDSCO pharmacovigilance requirements, and the Pharmacovigilance Programme of India (PvPI) standards. We process individual case safety reports (ICSRs), prepare Periodic Safety Update Reports (PSURs), conduct signal detection and evaluation, develop Risk Management Plans (RMPs), and manage regulatory submissions to the Indian Pharmacopoeia Commission.

As a CDSCO-approved CRO with integrated clinical trial and analytical capabilities, Auriga Research offers a unique advantage: safety data from clinical studies flows directly into our pharmacovigilance database without the delays and errors that occur when multiple vendors handle different phases of the product safety lifecycle.

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Pharmacovigilance Service Capabilities

Adverse Event Case Processing

Receipt, triage, data entry, medical coding (MedDRA), narrative writing, quality review, and regulatory submission of ICSRs within mandated timelines.

PSUR & PBRER Preparation

Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports per ICH E2C(R2) with cumulative data analysis and benefit-risk conclusions.

Signal Detection & Evaluation

Systematic statistical and clinical review of safety databases to identify, validate, and assess potential safety signals requiring regulatory action.

Risk Management Plans

Development of EU-format and CDSCO-format RMPs including safety specifications, pharmacovigilance plans, and risk minimisation activities.

Medical Literature Monitoring

Systematic screening of published literature for adverse event reports, safety signals, and relevant safety information per regulatory requirements.

Clinical Trial Safety Reporting

SUSAR (Suspected Unexpected Serious Adverse Reaction) processing, DSMB support, Development Safety Update Reports (DSURs), and expedited regulatory reporting.

Regulatory Framework & Compliance

Pharmacovigilance in India is governed by the Drugs and Cosmetics Act 1940, the New Drugs and Clinical Trials Rules 2019, and guidelines issued by CDSCO and the Indian Pharmacopoeia Commission. Marketing authorisation holders must establish and maintain a pharmacovigilance system, appoint a qualified person responsible for pharmacovigilance (QPPV), and submit periodic safety reports to the regulatory authority.

Our pharmacovigilance system master file (PSMF) documents all aspects of our PV operations. We maintain a validated safety database for case management, use MedDRA for medical terminology coding, and follow ICH E2B(R3) format for electronic transmission of ICSRs. All pharmacovigilance personnel are trained in GVP modules and undergo regular competency assessments.

Related Services

CRO Services Overview Full CRO capabilities Clinical Trials Phase I-III & bioanalytical Biostatistics Data management & analysis Medical Writing Regulatory submissions Pharmaceutical Testing Analytical & stability testing Nutraceutical Testing FSSAI compliance testing

Frequently Asked Questions

What is pharmacovigilance and why is it required?
Pharmacovigilance is the science of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It is a regulatory requirement under the Drugs and Cosmetics Act in India and equivalent regulations globally. CDSCO mandates that marketing authorisation holders establish pharmacovigilance systems to continuously monitor the safety of their products throughout their marketed lifecycle. Failure to comply can result in product suspension or licence cancellation.
Does Auriga Research serve as a pharmacovigilance service provider for CDSCO compliance?
Yes. Auriga Research provides outsourced pharmacovigilance services that satisfy CDSCO requirements for marketing authorisation holders. We serve as the pharmacovigilance partner handling adverse event case processing, PSUR preparation, signal detection, risk management plan development, and regulatory submissions to the Indian Pharmacopoeia Commission (IPC) and the Pharmacovigilance Programme of India (PvPI).
What is a Periodic Safety Update Report (PSUR)?
A PSUR (Periodic Safety Update Report) is a pharmacovigilance document that provides a comprehensive analysis of the global safety profile of a medicinal product at defined time points post-authorisation. PSURs include cumulative adverse event data, signal evaluations, benefit-risk assessment, and any proposed risk minimisation measures. Auriga Research prepares PSURs aligned with ICH E2C(R2) guidelines and CDSCO submission timelines.
How does signal detection work in pharmacovigilance?
Signal detection involves systematic analysis of adverse event databases to identify previously unrecognised safety concerns or changes in the frequency/severity of known adverse reactions. Our pharmacovigilance team uses statistical disproportionality analysis, case series review, and literature monitoring to detect potential signals. Validated signals undergo formal assessment and, where warranted, trigger risk management actions and regulatory notifications.
Can you handle pharmacovigilance for cosmetics and nutraceuticals?
Yes. While traditional pharmacovigilance focuses on pharmaceutical products, Auriga Research also provides cosmetovigilance and nutraceutical safety monitoring services. For cosmetics, we handle adverse event tracking under the Drugs and Cosmetics Act provisions. For nutraceuticals, we monitor safety under FSSAI regulations. Our approach adapts pharmacovigilance best practices to these product categories while meeting their specific regulatory requirements.

Set Up Your Pharmacovigilance System

CDSCO-compliant pharmacovigilance services including case processing, PSURs, signal detection, and risk management. Protect your products and patients.

+91-7428116100 Request a PV Proposal

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