Pharmacovigilance Services

A PV database is a secure system used to collect, manage, and submit adverse event reports. It ensures regulatory compliance and accurate tracking of safety data across product lifecycles.

MICC services include responding to medical inquiries, product information dissemination, adverse event intake, and complaint logging—all handled by trained healthcare professionals.

The Pharmacovigilance System Master File (PSMF) provides an overview of the PV system used by the Marketing Authorization Holder. It is a regulatory requirement in the EU and other markets.

An Individual Case Safety Report (ICSR) is a detailed record of an adverse drug reaction. We handle collection, MedDRA coding, narrative writing, quality control, and submission to EudraVigilance, FDA FAERS, etc.

Literature monitoring involves scanning scientific journals and databases for reports of adverse events or new safety concerns related to your products. It's a mandatory pharmacovigilance activity.

These are periodic safety reports required by regulatory bodies. PSUR (EU), PBRER (global format), and PADER (US FDA) summarize the benefit-risk balance of a product over a defined period.

An RMP outlines known and potential risks of a drug and describes how these will be minimized. It's essential for products with significant safety profiles or conditional approvals.

We follow a structured signal management process—detection, validation, prioritization, assessment, and recommendation—based on quantitative and qualitative safety data.

Our database setup includes implementation of validated safety databases like Argus Safety or Veeva Vault, workflow customization, MedDRA/WHO-DD coding, 21 CFR Part 11 compliance, and E2B R3 data exchange setup.

Our 24/7 MICC provides multilingual support for medical inquiries, adverse event intake, and product complaint triage, handling interactions from healthcare professionals and patients globally.

ICSR processing includes triage, data entry, MedDRA coding, narrative writing, seriousness/causality assessment, and submission to authorities like EMA, FDA, and DCGI using E2B R2/R3 formats.

We adhere to GVP Modules, ICH E2E, FDA 21 CFR Part 11, EU Annex 11, and regional requirements, with compliance monitoring, audit preparation, and CAPA management.

Pharmaceutical companies, biotech firms, generic and biosimilar manufacturers, and MAHs benefit by ensuring drug safety, regulatory compliance, and effective risk management.

Literature monitoring involves global and local surveillance for ADRs and safety signals using databases like Embase and PubMed, ensuring compliance with GVP Module VI.