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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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.
DIA Europe 2025 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2025 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.
We’re thrilled to announce that the web-based variations eAF is now ready for non-CAPs products across National Procedures (NP), Mutual Recognition Procedures (MRP), and Decentralized Procedures (DCP)! Starting today, eAFs
ASPHALION es una empresa internacional líder en Consultoría Regulatoria, Científica y de Seguridad en Ciencias de la Vida. Apoyamos a las empresas en el desarrollo y autorización de medicamentos, desde
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