eCTD Strategy and Implementation

Training on the Impact of the eCTD to Pharmaceutical Companies and National Competent Authorities.

Consultancy to align business processes with first-time-right eCTD lifecycle management, including:

  • Granularity of documents for eCTD

  • Development and use of document templates

  • Publishing of documents to fit into eCTDs

  • Naming conventions for file and folder names

  • Metadata selection for the benefit of applicant and reviewer

  • Lifecycle management for internal business processes

Advice on the maintenance of country-specific dossiers harmonized in a database to maintain compliance

Advice on structuring of a regulatory document repository

Project Management of the selection and implementation of software tools for publishing of documents and eCTD submissions

Training in document authoring to minimize future changes due to redundant referencing and/or redundant details

Training in strategic organisation of eCTD lifecycles to:

  • Allow optimal reuse of source documents

  • Minimise the number of documents to be included in subsequent variation dossiers

Provision of advice to software vendors related to the requirements of the Pharmaceutical Industry or National Competent Authorities

Consultancy to align review procedures to eCTDs within National Competent Authorities

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