Asphalion
✕
  • Home
  • About us
    • Mission, Vision, Values
    • Management and Directors
  • Services
    • Regulatory Strategy and Scientific Advice during Development
    • Medical and Scientific Writing
    • Horizon Europe Programme | Global Regulatory Partner​
    • Global Regulatory Submissions
    • eCTD and eSubmissions
    • ISO IDMP, Data Governance Services & RIM
    • Local Support and Regulatory Affairs Service Provider in Spain
    • Local Support in the UK – BREXIT
    • Medicinal Product Life-Cycle Management Outsourcing​
    • Pharmacovigilance and Drug Safety Services
    • CMC Regulatory Solutions
    • Medical Device Regulatory Services in EU and USA
    • Advanced Therapy Medicinal Products (ATMPs) & Biologics
  • Careers
    • Job Opportunities
    • Culture & values
    • Send us your CV
    • Life at Asphalion
  • News & Events
    • News
    • Events
  • Blog
  • Contact us

eCTD and eSubmissions

Icono-esubmissions

Achieve efficiency by using latest development and e-tools

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.

Do you need support or more information about the services? Contact us!




    I want to receive news and communications from Asphalion. yesno


    RELATED NEWS AND EVENTS

    Kick-off meeting| #SINPAIN project

    RBDCOV | HIPRA’s Covid-19 vaccine

    Kick-off | #SINPAIN project

    Tumor-LN-oC | 12-month follow-up meeting

    Did you know that?

    • Regulatory Strategy and Scientific Advice during Development
    • Medical and Scientific Writing
    • Horizon Europe Programme | Global Regulatory Partner​
    • Global Regulatory Submissions
    • eCTD and eSubmissions
    • ISO IDMP, Data Governance Services & RIM
    • Local Support and Regulatory Affairs Service Provider in Spain
    • Local Support in the UK – BREXIT
    • Medicinal Product Life-Cycle Management Outsourcing​
    • Pharmacovigilance and Drug Safety Services
    • CMC Regulatory Solutions
    • Medical Device Regulatory Services in EU and USA
    • Advanced Therapy Medicinal Products (ATMPs) & Biologics

    ASPHALION S.L.

    HQ – Barcelona
    info@asphalion.com
    +34 93 238 5945

    Munich Office
    munich@asphalion.com
    +49 (0)89 039 280

    Madrid Office
    madrid@asphalion.com
    +34 910 483 817

    London Office

    london@asphalion.com

    MEMBERSHIP

    CERTIFICATIONS

    ISO Certificate


     

     

    Seal of Innovative SME

    © All rights reserved - Legal disclaimer - Privacy policy -  Cookies Policy -  Quality Policy
    We use first party and third party cookies and for analytical and marketing purposes, as well as to share content on social media. Check our Cookies Policy for more information or click the below buttons as it corresponds.
    Accept all and continue navigating
    Configure or reject cookies
    Cookie Box Settings
    Cookie Box Settings

    Privacy settings

    Decide which cookies you want to allow.You can change these settings at any time. However, this can result in some functions no longer being available. For information on deleting the cookies, please consult your browser’s help function.Learn more about the cookies we use.

    With the slider, you can enable or disable different types of cookies:

    • Block all
    • Essential
    • Functionality
    • Analytics
    • Advertising

    This website will:

    • Essential: Remember your cookie permission setting
    • Essential: Allow session cookies
    • Essential: Gather information you input into a contact forms, newsletter and other forms across all pages
    • Essential: Keep track of what you input in a shopping cart
    • Essential: Authenticate that you are logged into your user account
    • Essential: Remember language version you selected

    This website won't:

    • Remember your login details
    • Functionality: Remember social media settings
    • Functionality: Remember selected region and country
    • Analytics: Keep track of your visited pages and interaction taken
    • Analytics: Keep track about your location and region based on your IP number
    • Analytics: Keep track of the time spent on each page
    • Analytics: Increase the data quality of the statistics functions
    • Advertising: Tailor information and advertising to your interests based on e.g. the content you have visited before. (Currently we do not use targeting or targeting cookies.
    • Advertising: Gather personally identifiable information such as name and location

    This website will:

    • Essential: Remember your cookie permission setting
    • Essential: Allow session cookies
    • Essential: Gather information you input into a contact forms, newsletter and other forms across all pages
    • Essential: Keep track of what you input in a shopping cart
    • Essential: Authenticate that you are logged into your user account
    • Essential: Remember language version you selected
    • Functionality: Remember social media settings
    • Functionality: Remember selected region and country

    This website won't:

    • Remember your login details
    • Analytics: Keep track of your visited pages and interaction taken
    • Analytics: Keep track about your location and region based on your IP number
    • Analytics: Keep track of the time spent on each page
    • Analytics: Increase the data quality of the statistics functions
    • Advertising: Tailor information and advertising to your interests based on e.g. the content you have visited before. (Currently we do not use targeting or targeting cookies.
    • Advertising: Gather personally identifiable information such as name and location

    This website will:

    • Essential: Remember your cookie permission setting
    • Essential: Allow session cookies
    • Essential: Gather information you input into a contact forms, newsletter and other forms across all pages
    • Essential: Keep track of what you input in a shopping cart
    • Essential: Authenticate that you are logged into your user account
    • Essential: Remember language version you selected
    • Functionality: Remember social media settingsl Functionality: Remember selected region and country
    • Analytics: Keep track of your visited pages and interaction taken
    • Analytics: Keep track about your location and region based on your IP number
    • Analytics: Keep track of the time spent on each page
    • Analytics: Increase the data quality of the statistics functions

    This website won't:

    • Remember your login details
    • Advertising: Use information for tailored advertising with third parties
    • Advertising: Allow you to connect to social sites
    • Advertising: Identify device you are using
    • Advertising: Gather personally identifiable information such as name and location

    This website will:

    • Essential: Remember your cookie permission setting
    • Essential: Allow session cookies
    • Essential: Gather information you input into a contact forms, newsletter and other forms across all pages
    • Essential: Keep track of what you input in a shopping cart
    • Essential: Authenticate that you are logged into your user account
    • Essential: Remember language version you selected
    • Functionality: Remember social media settingsl Functionality: Remember selected region and country
    • Analytics: Keep track of your visited pages and interaction taken
    • Analytics: Keep track about your location and region based on your IP number
    • Analytics: Keep track of the time spent on each page
    • Analytics: Increase the data quality of the statistics functions
    • Advertising: Use information for tailored advertising with third parties
    • Advertising: Allow you to connect to social sitesl Advertising: Identify device you are using
    • Advertising: Gather personally identifiable information such as name and location

    This website won't:

    • Remember your login details
    Save & Close