Following evidence generation that indicates a product has the successful adequacy to treat a medical need, an appropriate regulatory registration procedure is required prior to commercialization.
This entails the definition, execution and formatting of registration eCTD dossiers and their management in terms of timing and content presentation, which are usually subject to standard formats and procedures requested by multiple authority bodies in each regulatory framework. This involves also a contextualization of such procedures regarding the type of product and the medical need to be covered.
Asphalion’s expertise aims at ensuring timely commercialization given the complexity of multiregional contexts, which requires a proper planning and management of document submission and product registration.
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