Regulatory Submissions

PharOS’ regulatory affairs team displays a considerable amount of sensitivity in proposing and executing the strategy needed to obtain marketing approval in a way which will satisfy the authorities in terms of supplying all relevant objective data regarding the safety, efficacy and quality of a product.

PharOS’ services include the preparation of regulatory submissions including national and via the Mutual Recognition. In addition, we are able to provide dossiers in the Common Technical Document (CTD) format, suitable for pan-European submissions.

The compilation of clinical and non-clinical overviews, Summary of Product Characteristics and Patient Information Leaflets and labels (in all EU languages), and answering to authority response letters are provided.

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