What is a Pharmacovigilance Database?
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.
What services are included in a Medical Information Call Centre (MICC)?
MICC services include responding to medical inquiries, product information dissemination, adverse event intake, and complaint logging—all handled by trained healthcare professionals.
What is the PSMF and why is it required?
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.
What is ICSR and how do you process it?
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.
What is literature monitoring in PV?
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.
What are PSUR, PBRER, and PADER reports?
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.
What is a Risk Management Plan (RMP)?
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.
How do you manage safety signals?
We follow a structured signal management process—detection, validation, prioritization, assessment, and recommendation—based on quantitative and qualitative safety data.
What does your pharmacovigilance database setup include?
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.
How does your Medical Information Call Centre operate?
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.
What is involved in ICSR case processing?
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.
How do you ensure compliance with global PV regulations?
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.
Who benefits from your pharmacovigilance services?
Pharmaceutical companies, biotech firms, generic and biosimilar manufacturers, and MAHs benefit by ensuring drug safety, regulatory compliance, and effective risk management.
What is the role of literature monitoring in pharmacovigilance?
Literature monitoring involves global and local surveillance for ADRs and safety signals using databases like Embase and PubMed, ensuring compliance with GVP Module VI.
