eCTD Service

It was agreed by the Heads of Medicines Agencies (HMA) in Reykjavik on 28 February 2005 that by an agreed end-2009 deadline, the European regulatory agencies must have the infrastructure and processes in place to handle electronic-only eCTD submissions to successfully support the related decision-making processes for the authorisation of medicinal products within the European Union.

The eCTD format has become mandatory in key markets for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. Since January 2008, FDA CDER has required all electronic submissions be in the eCTD format. FDA CBER requires the eCTD format for priority review and rolling submissions.

eCTD Outsourcing

Pharmafile can help you prepare submissions in eCTD (or NeeS) and submitting these to the relevant Regulatory Agencies.

We can tailor our services for your company to include; Centralised (CP), Decentralised (DCP) and Mutual Recognition procedures (MRP), as well as National applications and the subsequent maintenance of the lifecycle including:

  • Initial application / Supplementary information

  • Variations /Renewals

  • Periodic Safety Update Reports (PSURs)

  • ASMF’s

  • and more

Pharmafile uses the Lorenz Docubridge as its Submission Management System, for the publishing and management of regulatory documentation. DocuBridge is widely used both in industry and regulatory agencies for eCTD and non eCTD electronic submission (NeeS).

Our Regulatory Affairs consultants are exceptionally competent in creating, publishing and submitting dossiers in both eCTD and non-eCTD (NeeS) formats.

For more information please contact us at: enquiries@pharmafile.ie