The document outlines the process for submitting regulatory documents for various markets, detailing the compilation and publishing steps of submissions, including the types of data and formats used. It includes information on electronic and non-electronic submission methods, data sources, and archiving procedures. The submission is managed through a database and involves various regulatory compliance elements for efficient processing and delivery.

1. Reuse published submission for other markets
S u b m i s s i o n
Process Diagram
Submission
from Alliance
Partner
Document Database
Documents for
submission are
created within, or
imported into the
database for
review/approval.
Data* for Submissions
Exported from various systems onto
network fileshares
*Defined as non-MS Office or PDF file
types
Data for submission:
• Case Report Forms
• SAS .xpt files
• Case Report Tabulations
• SDTM files for Clinical/Noncl. Data
• SPL files for Labeling
• SPL files for eListing/eRegistration
Documents and/or Data
Pulled into Submission Tools
Document & Data
Input Areas
Submission Compilation
& Publishing
Submissions published
to fileshares
eCTD Submission Format
Non-eCTD Submission Formats
M1
M2
M3
M4
M5
Modules 3-5
compiled/
published
by functions
Various Module 1
DTD required
EU
NeeS
ASEAN Other
Electronic
Published
Files on
FilesharesDigital or wet-ink
Signature applied
Robocopy
Regulatory
Status
Information
Submission Archival Fileshares
Dispatch Methods
(Whichever applies to the procedure/market)
Paper and/or Media
Health
Authorities
Email and
deliver via
zipped file on
Print Shop
Fileshare
Email URL
Email link to
Archival
Fileshare
Secure File
Transfer to
Alliance
Partner
Upload to
Health
Authority
Gateway/
Portal
Alliance Partner
Postscript files CD Tape
Request a free Demo of cune-eCTD info@cunesoft.com