At Stark Pharma, safety is at the core of every decision we make—from early development to post-market surveillance. Our integrated Pharmacovigilance (PV) and Medical Device Vigilance services ensure that both medicinal and device products remain safe, compliant, and effective throughout their lifecycle. We not only support global life sciences clients but also maintain robust internal vigilance systems for our own medical devices—setting industry benchmarks in safety compliance.
We offer comprehensive PV services including Individual Case Safety Reports (ICSRs), literature screening, signal detection, aggregate safety reports (PBRER, PSUR), and risk management plans. Our experts ensure global compliance with FDA, EMA, CDSCO, and other regulatory agencies.
We support device manufacturers with complaint management, reportable incident evaluations, adverse event reporting, and coordination of Field Safety Corrective Actions (FSCA). We ensure compliance with EU MDR, US FDA MDR, and CDSCO guidelines for post-market surveillance.
For medical devices, we manage a dedicated PQC framework that captures, evaluates, and escalates customer complaints related to device performance, safety, or malfunction. Our PQC system integrates complaint trending, root cause analysis, and Corrective and Preventive Actions (CAPA) to ensure continuous improvement and regulatory reporting.
As a manufacturer of Class II and Class III medical devices, Stark Pharma implements real-time safety tracking and post-market performance monitoring for its own products. We follow global vigilance standards, leveraging our in-house QMS, validated databases, and customer feedback mechanisms to maintain top-tier product safety and compliance.
We conduct proactive safety signal detection using trend analytics, periodic reviews, and product usage data. Our team formulates risk minimization plans and benefit-risk analyses to support regulatory submissions and labeling decisions.
We use 21 CFR Part 11-compliant electronic safety databases and offer QPPV and local affiliate support to maintain pharmacovigilance systems across EEA, India, and North America.
From ICSRs and PQCs to FSCA and aggregate reporting, we provide full-spectrum vigilance services for both third-party and in-house products.
As a dual-role organization—supporting clients and managing our own product safety—we bring a 360-degree understanding of vigilance, risk, and regulatory expectations.
We align with US FDA, EMA, EU MDR, CDSCO, and Health Canada requirements, ensuring proactive monitoring and zero tolerance for non-compliance.
+1 (732)760-5152
hr@starkpharma.com
