EU RA consultancy for post-authorisation life cycle management
In order to manage a product’s lifecycle in a competitive market place and environment of continuous scientific and technical progress, the marketing authorisation holders (MAHs) are faced with the need to submit Renewals, Variations, Line Extensions, Label changes, license transfers, switches of legal status, DHCP-letters, and other regulatory maintenance responsibilities. PhaRA can help MAHs to cope with these regulatory challenges and administrative burdens. Over the recent years we have played active roles in the regulatory aspects related to product divestures following mergers, acquisitions or selling of product portfolios.
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