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Medical devices and pharmaceuticals
This pack offers manufacturers a clear, compliant and controlled route to the authorization of placing on the market of their products. By centralizing the preparation of dossiers, interactions with competent authorities and post-authorisation obligations, it allows to reduce regulatory risks, avoid costly errors and ensure continuity throughout the product life cycle, from the initial submission for market release.
It offers structured and operational support, ensuring effective coordination with the competent authorities, the implementation of robust quality systems and continuous compliance throughout the life cycle of the installation.
WHAT THE OFFER INCLUDES
CTD submissions
Homologation files and forms
Handling of reimbursement procedures
Conformity assessment
Labelling compliance
Approval of marketing materials
Materiovigilance
Pharmacovigilance
Batch release
Legal representation
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