ASPHALION´S HIGHLIGHTS | Second quarter 2024
Highlights video
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.
Registration Solutions
Schedule a free meeting!
Discuss your case with our experts and receive a valuable feedback
Share
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
Highlights video
Highlights video
Highlights video
Highlights video
Highlights video
Highlights video
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.
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
ASPHALION és una empresa internacional líder en Consultoria Regulatòria, Científica i de Ciències de la Vida amb 25 anys a l’avantguarda en matèria reguladora. Donem suport a les empreses en
Services
By department
By stage of development
By product
By region
Other services
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
Cookie | Duration | Description |
---|---|---|
cookielawinfo-checkbox-advertisement | 1 year | Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Advertisement" category. |
cookielawinfo-checkbox-analytics | 1 year | Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Analytics" category. |
cookielawinfo-checkbox-necessary | 1 year | Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Necessary" category. |
cookielawinfo-checkbox-others | 1 year | Set by the GDPR Cookie Consent plugin, this cookie stores user consent for cookies in the category "Others". |
CookieLawInfoConsent | 1 year | CookieYes sets this cookie to record the default button state of the corresponding category and the status of CCPA. It works only in coordination with the primary cookie. |
elementor | never | The website's WordPress theme uses this cookie. It allows the website owner to implement or change the website's content in real-time. |
viewed_cookie_policy | 1 year | The GDPR Cookie Consent plugin sets the cookie to store whether or not the user has consented to use cookies. It does not store any personal data. |
wpEmojiSettingsSupports | session | WordPress sets this cookie when a user interacts with emojis on a WordPress site. It helps determine if the user's browser can display emojis properly. |
Cookie | Duration | Description |
---|---|---|
_ga | 1 year 1 month 4 days | Google Analytics sets this cookie to calculate visitor, session and campaign data and track site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognise unique visitors. |
_ga_* | 1 year 1 month 4 days | Google Analytics sets this cookie to store and count page views. |
_gat_gtag_UA_* | 1 minute | Google Analytics sets this cookie to store a unique user ID. |
_gid | 1 day | Google Analytics sets this cookie to store information on how visitors use a website while also creating an analytics report of the website's performance. Some of the collected data includes the number of visitors, their source, and the pages they visit anonymously. |
Cookie | Duration | Description |
---|---|---|
VISITOR_INFO1_LIVE | 6 months | YouTube sets this cookie to measure bandwidth, determining whether the user gets the new or old player interface. |
VISITOR_PRIVACY_METADATA | 6 months | YouTube sets this cookie to store the user's cookie consent state for the current domain. |
YSC | session | Youtube sets this cookie to track the views of embedded videos on Youtube pages. |
yt-remote-connected-devices | never | YouTube sets this cookie to store the user's video preferences using embedded YouTube videos. |
yt-remote-device-id | never | YouTube sets this cookie to store the user's video preferences using embedded YouTube videos. |
yt.innertube::nextId | never | YouTube sets this cookie to register a unique ID to store data on what videos from YouTube the user has seen. |
yt.innertube::requests | never | YouTube sets this cookie to register a unique ID to store data on what videos from YouTube the user has seen. |