Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Now a days in order to market any drug product need to get approval from concerned regulatory authorities by submitting the dossier via., CTD or eCTD formats. CTD is the agreement to compile all the facts on Quality, Safety, and Efficacy in a uniform format. Using the Electronic Common Technical Document (eCTD), CTD can be electronically submitted from the applicant to the regulator, such as the USFDA or EMA. The eCTD software underwent a lot of changes. Extedo/IABG Life Sciences are the companies that provide eCTD validator solutions. Data and information included in a regulatory submission must be gathered and managed for thoroughness, correctness, and integrity in accordance with agency criteria. The typical stages in the submission process flow are submission management, document level publishing, submission level publishing, validation and verification, and dispatch to agency. Based on the requirement of eCTD format in major market places companies must provide an uniform infrastructure that supports the lifecycle of every type of intrinsic submission. Under Industrial perspective, The static, PDF-locked documents provide particular difficulties for automation, dynamic data access, review, and analysis. Challenges faced by the companies from Health Authorities because the turnaround time for responses varies by region and can, in many cases be as little as a few days.