Achieve efficiency by using latest development and e-tools
We have been at the forefront of electronic submission of regulatory data since the introduction of eCTD.
We promote advanced use of e-tools for greater productivity in the preparation and submission of eCTD using Agencies’ gateways and portals while being in direct contact with the authorities.
- Comprehensive eCTD services
- eCTD compilation and publishing
- Full life-cycle support for Europe, USA, Canada, Switzerland, Saudi Arabia, GCC, and more
- Information Management (RIM solutions)
- xEVMPD and ISO IDMP experts
- Software installation, training, validation and support
Any help you might need with the preparation of baselines, understanding the world of eCTD or choosing the right software, Asphalion would be more than happy to support you and make your eCTD journey both valuable and pleasant.
Do you need support or more information about the services? Contact us!
Filtración Esterilizante y Aspectos Regulatorios – Jueves, 17/9 – Online Training by 3M & Asphalion
El próximo 17 de septiembre de 10h a 13h, 3M y Asphalion se unen en la I Sesión Formativa Online "Filtración Esterilizante y Aspectos Regulatorios" para contaros las estrategias y claves de éxito para vuestros procesos.
Advanced Therapies Congress & Expo 2020
Asphalion will be participating in the Advanced Therapies Congress & Expo 2020.
MDR | Guidance documents and updates on clinical investigation and evaluation
Although the date of application of the MDR has been postponed, on 26 May 2021 the Regulation will become fully applicable, following the transition period.
Summer – Asphalion does not close in August!
We will be open in August and available to attend all your needs and requests as usual!
2 clicks for a free 30-minute meeting!
Do you need regulatory support during your drug development? It has never been so simple to get it!
