Measures Taken for Submission of Successful eCTD Submission Software

 The struggle of eCTD is real. The regulatory submissions should indulge themselves in conforming to the electronic common technical document Software (eCTD Software) to be successfully received and reviewed by the health authority. 

History of eCTD Submission Software

eCTD was developed under the guidance of the International Conference for Harmonization multidisciplinary group. This group is an international organization that is indulged in developing international standards. 

The idea behind this organization is to review the drugs and the potentiality of all the regulated drugs in a streamlined manner. The eCTD Templates must be implemented in every health authority globally. 

Five modules that are contained in eCTD Submission Software are as follows-

• Common technical document summaries

• Clinical study reports

• Administrative information & prescribing information

• Quality

• Nonclinical study report

How does this eCTD mitigate your risks?

Two common regulatory pitfalls can invoke an RTF.

The failure in the submission is primarily based on technical. When the FDA receives a submission, they start using Global Submit to validate the tool. If there are some lacunae and serious validation errors while submitting, they will reject it immediately. 

Sometimes submission failure may be due to content. You may not have used the case report forms, or the data you have used may not be in the form of CDISC format. You may have also forgotten to include an integrated safety summary report that comprises all the safety information in the submission.

Ensure High-Quality Submissions

To avoid the risk of failing to meet the eCTD standards, there is a need to embrace the regulatory operations best practices. There is a need to incurring of an RTF from the agency.  

In this process, first of all, there is a need to take help from a regulatory writing standpoint by supporting the project management. After the writing of the medical, the documents is then prepared for the eCTD Submissions Software. 

The publishing service team then plays a vital role, and they manage the project from a submission standpoint. They also try to add all those needed reports to the eCTD Software and make sure that the submission procedure followed is valid and is easily accepted by the agency. 

Regional Documents Needed

eCTD requirements always differ from the other 2 regions in 2 ways- first of all, the difference in the module 1 content and second with the validation criteria. 

eCTD module 1 contains certain regional requirements, prescribing information, and some local government forms. Each of the regions has its submission specifications and requirements. European Union usually accepts also those submissions which use their centralized procedure. After that, it approves the drugs in all the markets of the European Union countries.

There are some additional criteria in which each region has its validation criteria, and this helps in scrutinizing the submission errors. In this way when each time a country updates the validation criteria or the local requirements, our team also updates the version of our submission validation software for that specific country or region. 

We are sure that you are going to appreciate the complexities involved in developing this eCTD Submission Software.