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    Product lifecycle management

    Obtaining a Marketing Authorisation (MA) is not the end but the beginning of your journey with Competent Authorisation. There are many duties and responsibilities placed upon the Marketing Authorisation Holder regarding maintenance of MA, e.g. timely payment of annual fees, updating the dossier in line with technological progress, application for safety variations and others. Moreover, as time passes, some post-authorisation activities should be carried out, although they are not obligatory, they do increase the attractiveness of the product. All of this adds up to product lifecycle management.

    SciencePharma offers wide range of product lifecycle management services keeping your MA and dossier always up-to-date and attractive:

    • all types variations management (type IA and IAin, type IB, type II variations and notifications)
    • line extensions applications
    • sunset clause exemptions applications
    • annual fees
    • renewals
    • withdrawals.

    How can we help You?

      Please be advised that the administrator of personal data entered in the above form is SciencePharma Sp. z o.o. with its registered office in Warsaw, Chełmska 30/34. These data are processed in order to receive incoming correspondence and respond to it. Providing personal data is voluntary, but necessary to send the form. Each person has the right to access their data and correct it.

      You can read the details on the protection of personal data here.