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!
Q&A document on the implementation of the MDR and IVDR
The EMA has recently revised the Q&A document that provides practical considerations concerning the implementation of the MDR and IVDR.
Graphene Connect on MedTech and Diagnostic Technologies
Yesterday, November 6, Dominique Monferrer and Eduardo Garrido participated in the event Graphene Connect on MedTech and Diagnostic Technologies associated with the first Graphene for Health Investment Forum.
Brexit | Very interesting and productive day!
Last week, Lidia Cánovas and Nuria Romero participated in the seminar “Els efectes del Brexit en el sector Farma".
La Castanyada & Halloween in Asphalion
Asphalion is celebrating both events on the same day. Do you celebrate these festivities in your company too? Trick or Treat?
Training session on regulatory approach of ICH Q12
Yesterday, Consol Bozzo Mulet and Daniel Langa García gave a training session on regulatory approach of "ICH Q12: Control de cambios. Consideraciones técnicas y regulatorias en el ciclo de vida de los productos farmacéuticos.”.
