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!
Mascarillas | Requerimientos a nivel regulatorio para su desarrollo y producción
Si estás trabajando en el desarrollo y producción de mascarillas, aquí tienes los requerimientos según las última actualizaciones a nivel regulatorio. No dudes en contactar con nosotros si necesitas ayuda: covid19@asphalion.com
Respiradores | Requerimientos a nivel regulatorio para su desarrollo y producción
Si estás trabajando en el desarrollo y producción de respiradores, aquí tienes los requerimientos según las última actualizaciones a nivel regulatorio. No dudes en contactar con nosotros si necesitas ayuda: covid19@asphalion.com
WEBINAR | Clinical Evaluation of Medical Devices according to EU MDR 2017/745
Don’t miss our last video in case you are interested in “Clinical Evaluation of Medical Devices according to EU MDR 2017/745” presented by Marta Rayo Lunar.
Asphalion is offering all its expertise in Regulatory Affairs
Asphalion and its experts are committed to bring solutions and alternatives to society during this exceptional situation.
Communications from Authorities in COVID-19 crisis
Asphalion has been closely following such publications to gather all possible information, while especially focusing on the Spanish situation. Here is a summary of the most important ones, organised by source, chronological order and scope: Communications from Authorities in COVID-19 crisis
