eCTD Editor® - services
We provide extended service for our clients:
- eCTD assistant
- documents preparation for different type of applications
- software support
The eCTD Editor does not need to be installed - it can be started immediately via web. Still, you can appreciate the assistance service in a specific case, e.g. if you have a lot of documents. We serve the software for you.
Documents preparation for different type of applications
We provide this service through our partner RECLINMED, s.r.o.
RECLINMED s.r.o. is a consultation company offering regulatory services for pharmaceutical industry since 2009.
As part of the support, our customers are also entitled to solve the formal issues related to the application. You may encounter, for example, the following issues:
- Query: How to fill the structure in the Control of Excipients section of Module 3 (3.2.P.4) without duplicating common files. CTD assumes for each type of substance separate folders with files corresponding to 3.2.P.4.1 - 3.2.P.4. Does this mean that the common files in sections 3.2.P.4.5 and 3.2.P.4.6 must be repeated in each folder?
- Query: We do not have the previous sequences in the eCTD format. The Authority now requires only the eCTD format. How do I refer to the documents in the previous version if they are not in electronic form?
- Inquiry: We have certain attributes in the initial registration. Now we initiate a new registration and need to change the value of one attribute. What is the correct procedure?
- Query: When is it necessary to include the TT [Tracking Table]
- Query: What are the rules for enumerating "Related sequences"? Can the software do it automatically?
eCTD Editor Support
These are services that are typically included in support for software products. It includes in particular:
- Our duty to keep the product up to date so it can be run in current versions of third-parties products
- Claim a new version of the product for free so that it still complies with the specifications
- Additional services
- Accelerated response time to errors (hours in case of critical errors)