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!
COVID-19 | AEMPS will carry out remote inspections of Good Practice in Pharmacovigilance
The AEMPS announced last week that in order to allow the normal activity of MAHs and to be able to supervise it adequately, the GCP and GMP inspection area will carry out remote pharmacovigilance inspections whenever possible.
COVID-19 | EMA decided to extend the MLM Service
The European Medicines Agency (EMA) decided to extend the Medical Literature Monitoring (MLM) service to cover substances used in products of interest in the COVID-19 context.
Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”
Last week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure".
New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU
The European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the European Union (EU).
Commission Implementing Decision C(2020) 2532
The European Commission (EC) has published a Commission Implementing Decision requesting a review (standardisation) of a set of existing standards, as well as new standards to be drafted, for support of Regulations 2017/745 (MDR) and 2017/746 (IVDR).
