Mandatory eCTD

Mandatory eCTD

Asphalion is an international Scientific and Regulatory Affairs consultancy with offices in Barcelona and Munich.

For eSubmission we provide a range of services:

  • Global eCTD publishing 
  • Implementation of eSubmission tools
    (eCTD, Pharmacovigilance, RIM)
  • xEVMPD maintenance
  • ISO IDMP implementation
With regards to eCTD publishing, Asphalion has over 10 years of experience with eCTD and support all EU procedure types (CP, MRP/DCP and NP), US (IND, NDA, BLA, ANDA) and other regions.
 
We are fully trained in Lorenz DocuBridge and already collaborate with different global companies for support for eCTD publishing, either in-house or with remote access. 

If you are looking for outsourcing peaks of eCTD publishing for submissions, maintenance activities and/or for support for validation, please contact us.

Besides experts in eCTD publishing, our consultants are in direct contact with the Authorities and would be happy to explain above services in more detail.a

If you provide your availability, we would be happy to set-up a TC for a free consultation.

Revive the FDA Open Seminar 2017 with this summary!
Asphalion in FDA!

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