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!
MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards
UPDATE: The corrigendum for the EU’s Medical Devices Regulation (MDR) granting manufacturers of Class I devices upclassified under MDR a four-year transitional period has been approved and published.
Formatted Letter Template | No longer maintained by EMA
As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.
Asphalion team wishes you a Merry Christmas and a Happy New Year
2020 is very special for us as we will celebrate the 20th Anniversary of Asphalion. Thank you for being part of it!
May 2020 | Only a few months remain for DoA of the new MDR
May 2020 is round the corner and therefore, only a few months remain for date of application (DoA) of the new medical device regulation (MDR).
AsphaNews | Last newsletter of the year 2019 🌠
Take a quick look at our latest newsletter and keep up to date with the latest news and events on the regulatory affairs and pharma sector. Subscribe to our newsletter and become an expert in Regulatory Affairs!
