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!
EU ISO IDMP Implementation Guideline – V1
Finally, EMA have released version 1 of the EU IDMP Implementation Guideline (EU IG v1).
Asphalion & Magic Line 2020
On March 1st Asphalion will join the solidarity march for the Hospital Sant Joan de Déu: La Magic Line.
Pharmacovigilance and Regulatory services in the UK
As of 1 February 2020, the United Kingdom (UK) is no longer an EU Member State and acts as a third country. This means that the UK no longer participates in EU institutions and their decision-making.
Today is the International Day of Women and Girls in Science
At Asphalion we work together with our clients to generate ideas and implement solutions that contribute to improve people's quality of life.
AsphaNews 2020 | First Newsletter of the year
Welcome back! Check out the first newsletter of the year to keep up to date with the latest news and events on the regulatory affairs and pharma sector!
