The core activity of Medius AG is to provide services in the field of regulatory affairs for pharmaceuticals and health products, including market authorization, quality assurance and development. The company particularly supports international companies in their market entry into Switzerland and offers consulting and services in these areas.
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Products & services
Industry:Pharmaceutical Industry
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Preparation and submission of approval documentation, life-cycle management, Swissmedic contact, submission strategies, technical documentation, due-diligence reviews, and regulatory training.
Quality Management for Medicines
Set-up and maintenance of GDP quality management systems, inspection management, GDP audits, GMP and GDP quality agreements, batch release, deviation and CAPA management, and training.
Representation Functions for GDP, Pharmacovigilance and Promotion
Assumption of the responsible person functions for GDP, pharmacovigilance and promotion in accordance with Swiss law.
Market Access Switzerland
Support for international companies without a Swiss subsidiary: application as local partner, Swiss-specific application file, submission to Swissmedic, registration management, and launch support.
Holder of the Marketing Authorisation
Assumption of the marketing authorisation holder role as an interim or long-term solution, with local responsible person, QMS, batch release, inspection support, and monitoring of distribution.
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