Contenu connexe Similaire à DMF in eCTD Format - Road to Readiness (20) 6. © 2017 Cunesoft GmbH 7
Tips for DMF Success from FDA
PDF Table of Contents and Bookmarks
– Should be the same
– For documents 5 pages or longer
– Up to 4 levels deep in hierarchy
Orientation
– Any documents provided in the submission should be in the correct orientation
Do not include form 356h when submitting via gateway.
– DMFs are automatically processed without the form
Scanned documents, including cover letters should be OCR’d prior to submitting
Leaf titles of documents should be clear and indicative of the document
Cover letters should include the sequence number and if possible, date of submission (e.g.
coverletter-0004Oct-13-2017)
Leaf titles for all annual report documents should include the reporting period (e.g. “AR-
specifications-Oct-122016-Oct-11-2017). That way, reviewers can differentiate between one year’s
report from another.
Cover letter should have contact information for agent, if applicable
Provide electronic submissions point of contact for technical issues
Provide correct telephone, email or fax number for rejection notices
10. © 2017 Cunesoft GmbH 11
Cunesoft’s Unique Value
People Products
Process
Cunesoft’s team is
comprised of highly
experienced professionals
who know and understand
the eCTD format and the
challenges you are facing as
you transition to this new
approach
Cunesoft has a well-tuned processes for helping
our clients get up and running with cune-eCTD –
from fast set-up, to training, to global support
Cunesoft’s technology
is built for ease of use,
ease of access, and
consistent compliance
with regulatory
requirements
11. © 2017 Cunesoft GmbH 12© 2017 Cunesoft GmbH 12
VERA – Online eCTD guide
Auto compile eCTD’s
PDF & OCR rendition engine
Incremental publishing
Validated according to FDA standards
eCTD 4.0 ready
ICH upgrades included & managed
SaaS - No installation needed
Automatic hourly system backup
Cunesoft Specials
Always compliant to latest ICH guidelines
Importer for eCTD’s/NeeS/CTD
Create and/or check hyperlinks
Manage eCTD lifecycle
Manually compile eCTD’s
Manage eCTD meta data
Multiple users work in parallel
eCTD viewer (delta, sequence,
cumulative and personal views)
Share submission output via portal
Re-use eCTD’s across the organization
Re-use documents for multiple eCTD’s
Publish CTD and NeeS
Automatic eCTD tree creation
Work from eCTD templates
Check for new document versions
Search as you type
eCTD compliance checker
DMS features included
Cunesoft – Time Savers
Global eCTD Management
cune-eCTD
cune-eCTD
Import or New eCTD’s
Auto Compile
Check Compliance
Submit to Gateway
The eCTD Basics
1.
14. © 2017 Cunesoft GmbH 17
The Road to DMF Readiness
Identify Your
Requirements &
Next Steps
1.
Understand the
eCTD &
submission
process
2.
Prepare your
sample ESG
submission &
submit
3. Prepare your
DMF submission
in eCTD
4.
Manage eCTD
Lifecycle
5.
Make your plan well in advance!
Checklist Description
What type of DMF filing is
planned?
Type II to Type V
Documents ready? All Documents available or pending
Document management system? Document management is in place to maintain documents
and versions
Software availability? Do you have software or you are going to outsource
Validator availability? Which validator to use for compiled output?
ESG account is setup? Do you have ESG account or you need to start process for
setting up
15. © 2017 Cunesoft GmbH 18
The Road to DMF Readiness
Identify Your
Requirements &
Next Steps
1.
Many new requirements, concepts and terminology
Checklist Description
Are your documents ready? Paper needing to be scanned? Electronic already?
Following CTD document granularity?
Which CTD sections apply to your type of DMF Different DMF Types utilize different sections of
the eCTD
Electronic Submission Gateway requirements The FDA’s ESG has specific requirements
Electronic Submission Gateway set-
up/registration
Give yourself enough time to get registered as it
can sometimes take up to 30 days
Understanding acknowledgements from
Gateway
Know how to interpret responses from the FDA
that are returned from the ESG
Understand the
eCTD &
submission
process
2.
Prepare your
sample ESG
submission &
submit
3. Prepare your
DMF submission
in eCTD
4.
Manage eCTD
Lifecycle
5.
17. © 2017 Cunesoft GmbH 20
The Road to DMF Readiness
Your successful transition to eCTD
Checklist Description
Organize your documents Is your metadata complete?
Are your documents in English?
Are any documents scanned PDFs?
Build your submission & test output Assign documents to proper folders
Ensure bookmarks & hyperlinks are in place
Enter appropriate envelope information
Test output with agency validator
Correct errors
Build your final submission output Generate final output and allocate sequence number
Transmit your final submission through
ESG
Send your submission to the FDA
Understanding acknowledgements from
Gateway
Receive response from ESG regarding acceptance
Identify Your
Requirements &
Next Steps
1.
Understand the
eCTD &
submission
process
2.
Prepare your
sample ESG
submission &
submit
3. Prepare your
DMF submission
in eCTD
4.
Manage eCTD
Lifecycle
5.
18. © 2017 Cunesoft GmbH 21
The Road to DMF Readiness
Understand your schedule
Checklist Description
Annual Reporting Know your schedule of annual reports
Amendments Only send new or updated information; do not resend previously
submitted files
Health authority
correspondence
Ensure timely response or actions to divisions and/ or approval
letters
Letters of Authorization Have a plan for how and when to submit
Identify Your
Requirements &
Next Steps
1.
Understand the
eCTD &
submission
process
2.
Prepare your
sample ESG
submission &
submit
3. Prepare your
DMF submission
in eCTD
4.
Manage eCTD
Lifecycle
5.
