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Outsourcing & Appointed Pharmacist
Outsource regulatory activities and Appointed Pharmacist support in Israel with Medicalix. Ongoing, project and interim support led by Avner Dor.
Service detailsOur expertise
Regulatory affairs services in Israel
Choose the support that fits your product and team. Medicalix provides ongoing outsourcing, defined projects and focused advice led by Avner Dor, with specialist partners involved according to the scope.
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Drug registration & submissions
Medicalix supports medicine registration in Israel: dossier readiness, Ministry of Health submissions and query coordination for human medicines.
Service details03
Medical devices & AMAR
Plan medical device registration in Israel with Medicalix: AMAR pathway assessment, document readiness, local responsibilities and submission coordination.
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Lifecycle management
Maintain your Israeli product portfolio with Medicalix: renewals, variations, leaflet and labeling updates, manufacturer coordination and regulatory tracking.
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Local entity & representation
Assess your Israeli local entity and regulatory representation model with Medicalix, including responsibilities, authorizations and manufacturer coordination.
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Strategy & market entry
Senior regulatory advice for entering Israel: product readiness, dossier gaps, local setup, priorities and launch planning, led by Avner Dor at Medicalix.
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Quality, QP & QPPV consulting
Medicalix provides QA, GMP/GDP, QP and QPPV consulting in Israel. Advisory support only, without appointed QP/QPPV roles or batch-release services.
Service details