Common Technical Document / electronic Common Technical Document

In July 2003, the common technical dossier (CTD) became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the FDA. The agreement to assemble all the quality, safety and efficacy information in a common format (called CTD – Common Technical Document ) led to harmonised electronic submission as electronic CTD (eCTD), which in turn enabled the implementation of facilitated review practices at authority site.

Our Service

We offer you a complete CTD/eCTD service for new drug applications and life cycle management, which comprises consultation, compilation, submission and maintenance. You as pharmaceutical company get the possibility to outsource parts of or the whole eCTD-compilation to us. By taking over the following activities Dr. Ebeling & Assoc. GmbH advises and supports you in all issues related to your CTD/eCTD project:

  • Ascertainment of regulatory requirements including Scientific Advice procedures
  • Planning and application of submission time slots
  • Development of marketing authorisation strategies (e.g. DCP, MRP, central procedure; full or abridged applications)
  • Compilation, maintenance and submission of the marketing authorisation application
  • Selection of the most appropriate processes and tools for your project
  • Region-specific advice (e.g. EU and US)
  • Preparation of CTD Modules (all or individual modules)
  • Conversion of the CTD to the eCTD format
  • Insertion of internal and external hyperlinks as well as bookmarks
  • Validation of the eCTD dossier
  • Updating and maintenance of the dossier (e.g. variations)
  • Document labelling and (re)tracing
  • Complete quality control of all documents
  • Secure archiving and forwarding of the eCTD dossier
  • Communication with regulatory authorities

Please do not hesitate to contact us for an individual offer.