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eSubmissions

Icono-esubmissions

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!




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    RELATED NEWS AND EVENTS

    #AsphaWellbeing: Asphalion´s new well-being programme for employees

    #AsphaWellbeing: Asphalion´s new well-being programme for our employees.

    Brexit advice: Schedule a meeting with us!

    Recently, we have received a lot of questions regarding Brexit and the changes it might imply for your business. Because of this, we are offering free consulting sessions with one of our Regulatory experts to discuss your projects and needs.

    Sonia López- New Pharmacovigilance Director at Asphalion

    Asphalion’s Board of Directors is pleased to announce the appointment of Sonia López as new Pharmacovigilance Director.

    Marta Rayo Lunar- New Scientific and Regulatory Affairs Director at Asphalion

    Asphalion’s Board of Directors is pleased to announce the appointment of Marta Rayo Lunar as new Scientific and Regulatory Affairs Director.

    BREXIT | Latest updates in Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

    As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.
    • Regulatory and Scientific Strategy during Development
    • Medical and Scientific Writing
    • H2020 Programme | Regulatory Partner
    • Global Submissions
    • eSubmissions
    • ISO IDMP & RIM
    • Local Support in Spain
    • Local Support in the UK – BREXIT
    • Life-Cycle Outsourcing
    • Pharmacovigilance
    • CMC solutions
    • Medical Devices
    • 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

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