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.
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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Why Asphalion?
Asphalion has a focused expertise in complying with challenging regulatory requirements, highly tailored for a wide diversity of regional contexts in which multiple agents intervene and allows Asphalion to be a leading partner on the execution, presentation and follow-up of technical regulatory documents, which allows contextualized product registration and maximized efficiency.
At Asphalion we know the requirements that documents must meet in order to be timely approved, especially in dossiers for registration procedures, such as CTD, technical documents for scientific reports or transparency compliance reports.
We cover all aspects, starting from scientific and medical writing, up to support of the registration procedure in compliance with the regulations of each country.
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