eCTD Editor - services

We offer the following services:

  • eCTD Assistant
  • eCTD Editor software support
  • consultations
  • preparing documentation before registration

eCTD Assistant

eCTD Editor in the Starter edition does not have to be installed – you can start using it through the website. Nevertheless, you may appreciate our assistance services in some situations, e.g. when you have a large number of documents. We will do the task using the software instead of you.

eCTD Editor software support

This service is a standard part of software product support. It includes in particular the following:

  • We are ready to provide you consultations
  • We have a duty to keep the product updated so that it can be run in current product versions of third parties
  • You are entitled to new product versions for free so that the product is always in line with specifications
  • We are ready to provide you trainings for a fixed price
  • We are ready to provide you additional work for a fixed price
  • Quick reaction in case of errors (hours in case of critical errors)

Consultations

As a part of our support, our customers are entitled to discuss problems concerning the formal aspects of creating a submission. You can be facing, e.g., the following issues:

  • Query: How shall we fill in the structure in the part called “Control of Excipients” of Module 3 (3.2.P.4.) without having to duplicate public files. CTD expects every type of substance to have its own folders with files in line with 3.2.P.4.1 - 3.2.P.4. Does it mean that public files from sections 3.2.P.5 and 3.2.P.6 need to repeat in every folder?
  • Query: Our initial submission is not in the eCTD format. Now the regulatory authority requires only the eCTD format. How shall we make references to documents from the previous version when they are not in electronic form?
  • Query: Our initial submission includes certain values of attributes. Now we follow the initial submission and we would need to change a value of one attribute. What is the right procedure?
  • Query: When do we have to present in connection with the submission the TT [Tracking Table] document?
  • Query: What rules are there for listing "Related sequences"? Can the program do it automatically?

Preparing materials for registration

We provide this service through our partners:

  • Biomedica, s.r.o. - Czech Republic
  • Archie Samuel, s.r.o. - Czech Republic
  • ASPharm, s.r.o. - Slovak Repulic