We have an innovative tool that produces an eCTD readiness report, based on responses given in an online questionnaire which is completed on an anonymous basis. The questions are of a general nature and relate to processes / procedures for submission preparation.  Users are not asked for any information that relates to particular projects or pharmaceutical products, and they are not asked to identify either themselves or their organisation.

The questionnaire covers general, document authoring, document management and submission publishing aspects. We believe that the report provides an excellent basis for discussions with management, consultants and vendors on how eCTD readiness should be addressed.

We hope that you'll find it useful. eCTD Readiness Tool