We specialize in helping biotech and pharmaceutical companies implement and maintain world-class pharmacovigilance (PV) and medical information (MI) systems.
With more than a decade of global experience, we provide tailored expertise – from negotiating PV terms and auditing PV systems in licensing in/out of products, acquisitions, co-development ventures to systems development including PV vendor selection, safety database migration, SOP development, inspection readiness, ICSR management, and aggregate reporting.
Our approach combines technical expertise, industry-proven practices, and business insight to ensure that every partnership, product launch, or safety operation is conducted with integrity and confidence. At the center of everything we do is one goal: maintaining regulatory compliance while enabling your business to grow safely and sustainably.
Over the years, we have successfully supported companies through complex inspections, global product launches, and international partnerships, always ensuring compliance with FDA, EMA, and ICH requirements. Our proven track record gives clients the confidence that their PV and MI systems are not only compliant, but also efficient and future-ready.
Choosing us means gaining a partner who understands both the science of safety and the business of pharmaceuticals – delivering practical solutions that align with your regulatory obligations, strategic goals, and commitment to patient safety
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