Comprehensive
Pharmacovigilance Solutions
At Mitan Pharma, we protect patients and support the pharmaceutical industry with comprehensive pharmacovigilance services. Our solutions are designed to monitor, assess, and minimize drug-related risks — ensuring that every product remains safe, effective, and fully compliant throughout its entire lifecycle.
From adverse event monitoring and ICSR case processing to aggregate safety reporting and post-marketing surveillance, our experienced team delivers tailored pharmacovigilance support grounded in FDA, EMA, and ICH regulatory standards.
ICSR Management
We handle the complete lifecycle of Individual Case Safety Reports — from initial data entry and thorough medical review to accurate MedDRA coding, detailed narrative writing, and submission within regulatory timelines to health authorities worldwide.
Safety Data Management
Our team ensures that all safety data is captured, stored, and managed with the highest level of accuracy and security. Using validated pharmacovigilance systems, we maintain complete audit trails and full lifecycle traceability for every safety record.
PSUR & DSUR Reporting
We prepare, review, and finalize Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) in full compliance with ICH E2C and E2F guidelines, enabling continuous and structured benefit-risk evaluation of your products.
PSMF / PvMF
We develop and maintain your Pharmacovigilance System Master File as a living document that accurately reflects your entire PV system — ensuring it remains inspection-ready and aligned with EMA and global regulatory expectations at all times.
Risk Management Plans (RMP / REMS)
Our regulatory experts design robust Risk Management Plans and Risk Evaluation and Mitigation Strategies that identify, characterize, and minimize product-related risks — while ensuring post-marketing safety obligations are clearly defined and executed.
Literature Surveillance
We conduct systematic and periodic reviews of global scientific and medical literature to proactively detect emerging safety signals, potential adverse effects, and new benefit-risk considerations — keeping your pharmacovigilance program continuously up to date.
Medical Inquiry & Complaint Handling
Our specialists manage the end-to-end process of product complaints and unsolicited medical queries with professionalism and precision — ensuring timely, accurate, and regulatory-compliant responses that safeguard both patients and your brand reputation.
QPPV Support Services
We provide dedicated support to your Qualified Person for Pharmacovigilance in fulfilling their regulatory responsibilities — including system oversight, signal management, regulatory liaison, and ensuring your PV system operates in full compliance.
Connect with our pharmacovigilance specialists today and discover how Mitan Pharma can
help you build a compliant, resilient, and patient-focused drug safety framework — tailored to
your specific needs and regulatory obligations.