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.
Related Resources
The Access consortium is a medium-sized coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the UK that work together to promote greater regulatory collaboration and alignment of regulatory requirements.
Asphalion contributions to the fight against COVID-19
(CTR) No 536/2014
Asphalion provides comprehensive support during development, certification, registration and post marketing of Medical Devices, IVDs and Combination Products in Europe, US as well as other regions.
La formación y conocimiento del Sistema de Autorregulación de Farmaindustria forma parte del compromiso que las compañías farmacéuticas y las personas que trabajan en ellas deben tener presente en su toma de decisiones.
A lot of things have happened at Asphalion during these past three months, and we have summarized the highlights in a two minutes video. You can watch it HERE: Hope
The conference will bring together key stakeholders, including leading regulators, industry experts, and European institution officials, to engage in discussions and debates on the regulatory challenges and opportunities that lie ahead.
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