eCTD and eSubmissions

At Asphalion, we have been at the forefront of electronic submission of regulatory data since the introduction of eCTD.

eCTD

The electronic Common Technical Document, or eCTD, is a standard format required by Health Authorities to submit regulatory data.

The importance of eCTD in regulatory affairs is that it allows to provide detailed information about drugs and medicines with the objective to obtain approval from the agencies involved in regulating the marketing authorization of medicines.

This electronic submission has been adopted by United States and the European Union among many other regions.

Agencies around the world that support eSubmissions

Some examples of regulatory agencies around the world are:

• FDA – The Food and Drugs Administration (USA);
• MHRA – The Medicines and Healthcare products Regulatory Agency (UK);
• EMA – The European Medicines Agency (European Union).

eSubmissions software

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.

What eSubmissions services do we offer

• 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 electronic submission software, Asphalion would be more than happy to support you and make your eCTD journey both valuable and pleasant.