pharmacovigilance
At MedtrackInsight, we provide comprehensive pharmacovigilance solutions designed to ensure the safety and efficacy of medicinal product.Our team specializes in adverse event detection, case management, signal detection, and aggregate safety reporting.We follow global regulatory standards including EMA, FDA, and CDSCO to maintain full compliance and data integrity.Our expertise covers Literature Monitoring, Medical Review, Audit Support, and Safety Writing & Documentation.We assist organizations in setting up robust PV systems, managing CAPA, and ensuring inspection readiness.With our end-to-end PV services, we help clients protect patient safety, strengthen regulatory confidence, and enhance post-marketing surveillance
Pharmacovigilance Setup & Compliance
We provide end-to-end support for establishing robust pharmacovigilance systems compliant with global regulatory standards.Our services include SOP development, QPPV setup, safety database implementation, and audit readiness.With MedtrackInsight,organizations can achieve seamless compliance with EMA, FDA, and CDSCO requirements while ensuring continuous drug safety monitoring.
Case Management
We offer comprehensive case management solutions covering the entire lifecycle of adverse event reporting.Our experts handle case intake, data validation, medical assessment, coding, and expedited submissions with accuracy and compliance.MedtrackInsight ensures timely, regulatory compliant processing to maintain product safety and global reporting standards.
Aggregate Safety Reporting PSURs / PBRERs, DSUR and PADER drating and submission
At MedtrackInsight, we provide end-to-end support for aggregate safety reporting, including the preparation and submission of PSURs/PBRERs, DSURs, and PADERs in compliance with global regulatory requirements. Our expertise ensures that all safety reports are scientifically sound, data-driven, and aligned with EMA, FDA, and CDSCO guidelines.Our medical writing and safety teams work collaboratively to analyze cumulative safety data,evaluate benefit–risk profiles, and highlight key safety trends. Each report is prepared with precision to reflect accurate global and local safety information, ensuring timely submissions and regulatory compliance.
Safety Writing & Documentation Narrative writing, SOP development, CAPA drafting
Our team of experienced medical writers and safety experts craft clear, concise, and high-quality narratives that effectively communicate patient case details and safety outcomes. We maintain consistency across all documents — from Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs) to Risk Management Plans (RMPs) and Development Safety Update Reports (DSURs).Beyond writing, we assist in developing and maintaining Standard Operating Procedures (SOPs), drafting Corrective and Preventive Actions (CAPA), and supporting audit readiness
Audit & Inspection Support
We offer complete audit and inspection support to ensure your pharmacovigilance system meets global regulatory standards. Our services include audit readiness checks, CAPA response management, and detailed mock audits.MedtrackInsight enables organizations to identify compliance gaps early and maintain continuous inspection preparedness with confidence
Literature Monitoring & Medical Review Global & local literature search, screening, and assessment
We conduct global and local literature searches to identify safety data, adverse events, and emerging drug information.Our team performs systematic screening and medical assessment of scientific publications to ensure regulatory compliance.MedtrackInsight’s expert reviewers deliver timely insights that strengthen signal detection and support pharmacovigilance reporting