Preparing Compliant eCTD Submissions

Preparing Compliant
eCTD Submissions

Antoinette Azevedo, President
e-SubmissionsSolutions.com

DocTrain Life Sciences, Indianapolis, IN
24 June 2008
Copyright 2008 e-SubmissionsSolutions.com 1

Agenda

RTF Case Study
What Can Go Wrong?
How to Assure Compliance of Source
Files?
eCTD Workflow
Questions & Discussion


Four Keys to eCTD Success

Content Process

Standards Technology


Refuse-to-File (RTF)
Case Study


The Guidance on RTF . . .

July 2006, US FDA, “Providing Regulatory Submissions in Electronic Format – Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD
Specifications,” Revision 1, 7087rev.pdf.


A Picture through Stock Price


Summer 2005
Small California Biotech-- Submits NDA in eCTD
format to FDA CDER
eCTD publishing system
PDF toolkit
Electronic document management systems
Documentum
OpenText LiveLink
Consultants
PDF preparation
eCTD publishing & QC


The Business Overview

NDA is company’s first candidate for
commercialization
Company is partnered with big pharma
who will assist with international sales
and marketing post-approval
Company hires 200 person sales force in
anticipation of approval


Fall 2005

FDA issues Refuse to File (RTF) under
PDUFA timeline
Inadequacy of individual PDF files
Navigability of content of submission
Market capitalization drops 50%
overnight
Analyst conference call


Early 2006

Small biotech prepares resubmission
Rework source files
Rework CTD folder/file structure
Rebuild XML backbone
FDA accepts resubmission for review
under PDUFA timeline


May 2006

FDA issues “approvable” letter under
PDUFA:
Drug could be approved in future if certain
conditions could be met
“Conditions” to be determined in future
meeting with FDA


June 2006

Big pharma company withdraws from
partnership


July 2006

Small biotech lays off sales force


August 2006

Small biotech lays off more than 100
additional employees


September 2006

Small biotech has meeting with FDA
concerning “approvable” conditions
Additional studies required
Additional analysis required


January 2007

Biotech announces plans to resubmit
NDA by 2Q2007


August 2007

FDA accepts NDA for review
FDA sets PDUFA action date of
12 December 2007


December 2007

Company Announces Sale and Leaseback
of Real Estate Assets
Deal valued at $109M
Net $61M after fees, expenses, etc.
Leases back corporate headquarters


December 2007
FDA issues “approvable” letter under PDUFA
deadline:
Objective/subjective trial in elderly
Comparator safety study
Preclinical evaluation during 3rd trimester of pregnancy
Company cuts half its workforce
Company prepares meeting request to FDA
Ceases all clinical development and pre-
commercialization activities for candidate drug


January 2008

Founder-President-CEO resigns after 14
years of service
Granted a formal meeting with FDA
during 1Q08 to discuss 2007 Approvable
Letter


February 2008

Hope springs eternal . . .
$20.0 million upfront license fee paid for drug
candidate rights for Japan
Balance sheet assets of $276.7 million
10 indications
Three programs in Phase 1-2 for 7 indications
Three research programs


What Can Go Wrong
with an eCTD?


FDA’s Top 12 Issues for
eCTD Success*
12. SPL must be in “SPL” folder
11. Use elements and leaf titles correctly
10. Always reference all files in the XML backbone(s)
9. Include Module 1 in All eCTD Submissions
8. Make sure all application numbers are 6 digits
7. Make sure all sequence numbers are 4 digits
6. Do not use node extensions
5. Verify that all MD5 checksums are correct
4. All documents should conform to eCTD granularity
3. All XML must use standard components

*Source: Virginia Ventura, FDA CDERPDF hyperlinks & bookmarks
2. Be sure all Office of Business Process Support are correct
1. Include TOCs in all PDF documents

Technical Issues with eCTD*
12. SPL must be in “SPL” folder
11. Use elements and leaf titles correctly
10. Always reference all files in the XML backbone(s)
9. Include Module 1 in All eCTD Submissions
8. Make sure all application numbers are 6 digits
7. Make sure all sequence numbers are 4 digits
6. Do not use node extensions
5. Verify that all MD5 checksums are correct
3. All XML must use standard components

*Source: Virginia Ventura, FDA CDER Office of Business Process Support

Technical Issues with Source
Files*
4. All documents should conform to eCTD granularity
2. Be sure all PDF hyperlinks & bookmarks are correct
1. Include TOCs in all PDF documents

*Source: Virginia Ventura, FDA CDER Office of Business Process Support

What is
CTD/eCTD? Module 1
Not part of CTD
Module 1
Regional Info

2.1 Table of Contents

2.2 Introduction
Module 2
2.3 2.4 Nonclinical 2.5 Clinical Summary
Overview Overview
Quality
Overall
2.6 Nonclinical 2.7 Clinical
Summary
Summary Summary

Module 3 Module 4 Module 5
Quality Safety Efficacy


What is CTD/eCTD?

Submission
“nda121212”
Sequence “0000” with
5 modules
Sequence “0002” with
4 modules


Where is XML Required?
“XML backbone”


As the FDA Sees an eCTD


Where is XML Required?
Module 1 Regional


Where is XML required?
Structured Product Labeling
(SPL)


Module 4 Study Tagging File
(STF)


STF for Module 4


Module 5 Study Tagging File
(STF)


STF for Module 5


Potential Problems with XML

Sponsor’s hand coding of XML
eCTD publishing vendor misinterpretation of
XML document type definition (DTD)
Sponsor’s usage of eCTD publishing system
eCTD publishing vendor not providing enough
guidance and control of user actions


What is XML?

Document/data interchange standard
Originated from SGML/HTML
Replaces traditional submission table of
contents
Rules for individual instances contained
in Document Type Definitions (DTD) or
Schemas

What is XML?


Challenges of eCTD:
The Numbers
According to FDA CDER:
NDAs will have multiple submissions over their life-
cycle
Of 10 most active eNDAs:
6 had 111 to 139 submissions
1 had 185 submissions
1 had 202 submissions
Of eSubmissions:
One initial submission had 5478 files
One eCTD supplement had over 15,000 files


Challenges of eCTD

Document Authoring -- Creation of PDFs
highly dependent on use of word
processor
Templates
Styles
Cross references – how & to what
Within document
Outside document


Challenges of eCTD
Granularity of content organization
Module 2: Quality, Nonclinical, Clinical summaries
Module 3: Quality
Module 4: Nonclinical study reports
Module 5: Clinical study reports
Regional differences
US
Integrated Analysis of Safety (IAS—formerly ISS)
Integrated Analysis of Efficacy (IAE—formerly ISE)
EU
Expert reports
CRFs – in or out
CRTs – in or out


Challenges of eCTD
Collecting documents/data from study sites
Case Report Forms
Cost/time to convert to compliant electronic format
Consistency of organization
Changes of study protocol
Different CROs involved in different study phases
Electronic Data Capture (EDC)
Location of queries & data correction forms (DCFs)
Does my drug’s indication imply need to review CRFs?
Which CRFs will I need to submit?
Deaths/Drops/Serious AEs
All
Other


Challenges of eCTD
Documents/data from study sites
Data
Can all the data be delivered in electronically-reviewable
format?
Can I convert from proprietary formats into SAS XPT
compliant formats?
Excel
Access
Other
Will the agency review my electronic datasets?
Stability
Nonclinical
Clinical


Challenges of eCTD
Electronic Document Management Systems (EDMS) vs.
Shared File System
How do I know I have the final, approved document?
What if the final, approved document changes?
What is the effective version for a submission sequence?
Do I have the time/budget/resources to implement EDMS?
Will the EDMS meet the needs of my entire enterprise?
Will the EDMS integrate with my e-Submission publishing
process and tools?
How do I assure the EDMS is 21 CRF 11 compliant?


eCTD Challenge: The Granularity

FDA CDER Study Tagging Files
Scope – nonclinical & clinical study reports
Lifecycle – from initial IND to product end-of-
life
Small unit of document granularity
Hyperlinking between files
Hyperlinking between submission serial numbers
A cultural change for most CROs and authors


Granularity – Quality Overall
Summary


Granularity –
CMC/Quality Drug Product


Study Report Granularity


US, EU, Japan Experience To
Date
Problems with PDF Files
Lacking navigation aids:
Bookmarks
Hyperlinks
Document tables of contents
Absolute paths on hyperlinks
Security
File format
Incorrect granularity
Referencing proprietary style sheets


Conclusion from Experience to
Date
System is needed to produce XML backbone
Source documents and data need to be
submission-ready & compliant with
requirements
Sponsors need intimate knowledge of the XML
output of their commercial-off-the-shelf (COTS)
systems
Sponsors must understand how agencies use
the components of an eCTD for review



Content Process



How to Assure Compliance
of Source Files?


Credits & Disclaimers
MS Word templates courtesy Sage Submissions LLC
http://www.sagesubmissions.com/
MS Office version 2000 Professional
Adobe Acrobat 2007 Professional
http://www.adobe.com/products/acrobat/index.html
MS Windows XP Professional 5.1 (SP2)
ISIToolbox Pharma Edition 5.5.1
http://www.imagesolutions.com/Default.aspx?alias=www.
imagesolutions.com/isitoolbox


Credits & Disclaimers

Enfocus PitStop Professional 7.01
http://www.enfocus.com/product.php?id=855
eCTD sample courtesy GlobalSubmit
http://www.globalsubmit.org/
Parsing/validating samples courtesy
GlobalSubmit & ING America
http://www.ingamerica.com/


FDA Portable Document
Format Specifications
http://www.fda.gov/cder/regulatory/ersr/
PDF_specification_v11.pdf
Examples follow . . .


PDF Version 1.4

Options:
“Reduce file size”
Output by EDMS
or eCTD
publishing system


Embed Fonts
Not needed
for standard
font sets
Options
Converting
from MS
Word
Setting in
Acrobat
Distiller


Embed Fonts

Options
Embed from within
Acrobat Standard or
Professional
Done on a text blocks
Not recommended
unless no other option


Embed Fonts

Options
Enfocus PitStop
Professional
Done a line at a time
Not recommended
unless no other option


Page Orientation


Page Size & Margins


Source of Electronic Document

Avoid scanning unless no other choice
Create PDFs from intelligent source
MS Office—Word, Excel, PowerPoint
Other word processors, spreadsheets, etc.
ASCII text
PDFs should be:
Searchable
Copy & paste to edit in other documents


If You Must Scan
Document Type Resolution

Handwritten notes 300 dpi (black ink)

Plotter output graphics 300 dpi

Photographs—b&w 600 dpi (8 bit gray scale)

Photographs—color 600 dpi (24 bit RGB)

Gels and karotypes 600 dpi (8 bit grayscale depth)

High pressure liquid chromatography 300 dpi

Lossless Image Compression
for Scanned Documents
Black & White Image Color & Grayscale
CCITT Group 4 Fax Zip/Flate

Reduce file size
No loss of data


Image Color Matching
CMYK for display
Pantone for printing
http://www.pantone.com/pages/pantone/index.
aspx
Calibrated lookup tables for printers
Printer application support files
Adobe Illustrator, Photoshop, Indesign
Macromedia Freehand
CorelDraw
Quark Xpress


Hypertext Linking

Navigation improved for PDF documents
Hypertext links for:
Annotations
Related sections
References
Appendices
Tables or figures
For anything not located on same page


Table of Contents & Hyperlinks

Hyperlinks designated by blue text or rectangles
with thin lines
Blue text for PDFs from intelligent source
Thin rectangles only option for scanned documents
Tables of Contents
Hyperlinked
Invisible rectangles and blue text preferred
eCTD publishing system can automate some


Use Relative Paths for
Hyperlinks

eCTD publishing system should generate automatically

Use Relative Path for Hyperlinks

However!
Acrobat still
shows relative path

Link report courtesy Image Solutions, Inc.
ISIToolbox Pharma Edition
Bookmark & Link Auditor,
Export Bookmarks and Links


Bookmarks Hierarchy
= TOC Up to 4 Levels



Bookmarks & Hyperlinks
Magnification
= Inherit Zoom

should generate
automatically

Link/Bookmark report courtesy
Image Solutions, Inc.
ISIToolbox Pharma Edition
Export Bookmarks and Links


Page Numbering
Document Page = PDF Page


Initial View = Bookmarks & Page



File Naming & Folder/File Path
Use lower cases letters
Avoid special characters
except hyphens
File/folder path:
230 characters for full
folder/file path
64 characters for folder
names
should generate/truncate
automatically


Verbally Communicated
Requirements
Open to TOC
Optimize for Fast Web View
Font size
12 point font for text
10 point for tables (9.5 pt)


Open to TOC Page


Open to TOC


Optimize for Fast Web View


Institute Standards for Data

Inside and outside suppliers
Datasets – must have complete
documentation
Datasets table of contents
Variable definition file—complete
Datasets in SAS transport
Annotated CRF (for human studies)


Complete Datasets Documentation


Bookmarking of CRFs



Content Process



eCTD Workflow


eCTD Single “Document” Workflow
Compile to
Collect Source Verify Single Files or Release for
Documents Completeness Study Tagging Files Publishing
& Data (STF)

If incomplete,
Incorrect, or
PDF Deliverables – Individual Files Content revised
Bookmarks & hyperlinks
Tables of contents
Pagination 1 through n
Optimized for fast web viewing
File Format 1.4

eCTD Submission Workflow
Prepare Repository Insert Content in Insert Cross- Output
for Handoff eCTD Outline Document Hyperlinks for QC

Set Submission Adjust Submission
& Document & Document Issues?
Attributes Attributes

• Invalid XML
• Source document changed
• Dead or missing bookmarks or hyperlinks


Components of an EDMS
Authoring
Client

Scanner

EDMS Server
Rendition Server RDBMS
for PDF Renditions & File Store


Components of Submission
Publishing System e-Submission

Publishing
Client
File
Server

FDA
ESG

EDMS Server, Publishing Server,
RDBMS & RDBMS p-Submission
& File Store

Web
Server

TimeLine for Implementation
Implementation Steps 1Q 2Q 3Q 4Q 5Q 6Q

Gather EDMS & eCTD system requirements;
determine validation requirements
Identify potential vendors; select short list

Prepare & issue RFP, reduce vendor list, start
negotiations
Order & install hardware; install EDMS software,
perform IQ/OQ validation
Train users, help desk, administrators; perform
EDMS UAT & PQ validation
Install & validate eCTD software. Produce small
submissions – INDs, Annual Reports, Amendments,
Supplements, Safety Updates
Produce marketing application & submit


Consistency of
eCTD across ICH

Vendors’ ability to offer Sponsors’ systems
inexpensive solutions ability to manage
for multiple eCTD lifecycle metadata
markets’ requirements over drug’s lifetime

eCTD Critical Success Factors

eCTD: Challenges to Sponsors

Return on Investment (ROI)
Cost of systems, training, process redesign
Cost of noncompliance
Speed, efficiency
Submission compilation
Agency review process
Lead time to application submission
On-going compliance


eCTD: Benefits to Sponsors:

Electronic content for sponsor’s internal access
(Potentially) faster agency review
Higher quality agency review
Demonstrated lower cost of production
compared with paper
Faster time from database lock to submission


Status of eCTD Requirements

FDA CDER
eCTD mandated January 1, 2008+ for electronic
submissions
CBER
Accepting both eCTD and eBLA
Sometimes e-submission mandatory (fast-track, rolling
submissions)
FDA CDRH
Guidances required
Informal pilots underway
Turbo 510K http://www.fda.gov/cdrh/cesub/index.html
Global Harmonization Task Force (GHTF) and STED

Status of FDA ESG

e-Sub May 2006 May 2007 Feb 2008 Total
AERS 9,109 12,917 247,925
CDER 20 1,009 15,931
CBER 6 101 2,146
CDRH 153 75 3,364
CVM 414
Totals 9,228 14,201 269,780


Business Case for ESG

1500 submissions (non-AERS)
Manual submission of electronic media &
supporting paper = $111,183
ESG startup (training, security certificates,
hardware) = $30,999 . . . $20.00+
Time/resource efficiency for Sponsor &
Agency


Business Case Against Paper

10 copies, 100 volume submission
$163,290 Total
$147,000 = printing
$5,790.00 = binder materials
$10,500.00 = shipping
Does not include labor to assemble, page
stamp, manual TOCs, binding, QC, labeling,
packing



Content Process



Status of eCTD Requirements

EU/Japan/Canada
PDF reviewers’ aids accepted along with paper
volumes
eCTD dependent on each country’s information
technology infrastructure
Needs early & frequent communication to determine
ability to accept & review
Rest of World
Highly dependent on information technology
infrastructure to review e-submissions


EMEA eCTD Statement of
Intent
1 July 2008 – accept eCTD or non-eCTD
electronic-only
1 January 2009 – strongly recommend eCTD or
non-eCTD; paper an exception
1 July 2009 – strongly recommend eCTD; paper
and other formats an exception
All applications (new and existing)
All submission types for Centralised Procedure
Rapporteurs & CHMP members receive no paper or
other electronic formats beyond this date


Japan eCTD Experience

MHLW statistics as of December 2007:
Original Applications = 6 (13 sequences)
Reference Applications = 52 (70 sequences)
Total = 58 (83 sequences)
Free eCTD Validator
Integrating eClinical Trial and eSubmission
throughout drug development lifecycle
CDISC standars for clinical trial data


Health Canada eCTD Transition
Phase 1 – Co-submission
Original Submission: eCTD Format on CD and DVD along with full
paper-based submission in CTD format
Subsequent Submissions: Continue use of both formats
Phase 2 - Hybrid submission
Original Submission: eCTD format on CD and DVD along with
Module 1 and 2 only in paper-based CTD format
Subsequent submissions: Submit Modules 1 & 2 in both formats
Original & Subsequent Submissions: Modules 3 to 5 may be subject
to print-on-demand requests
Electronic-only
Original Submission: eCTD format with no accompanying paper
Subsequent submissions: Do not revert to paper-based CTD


Health Canada: Criteria for Participation in
the Hybrid Filing Format Pilot

Guidance January 25, 2006 December 31, 2007
Comparison (for pilot beginning on June 30, (effective immediately)
2006)
Candidate Submission has priority review status New Drug Submissions (NDSs),
submission Submission qualifies under the Abbreviated New Drug Submission
types Notice of Compliance with conditions (ANDS), Supplement to a New Drug
(NOC/c) policy Submission (SNDS), Supplement to a
Health Canada does not have Abbreviated New Drug Submission
capacity or ability to perform (SANDS)
electronic review NDS labeling only if the original
Submission to be assigned to a submission was filed in the co-submission
reviewer on contract or a teleworker or hybrid filing formats
Notifiable Change submissions and annual
updates of Notices of Change related to a
previously filed eCTD submission that was
filed in the hybrid filing format


Health Canada: Criteria for Participation in
the Hybrid Filing Format Pilot

Guidance January 25, 2006 December 31, 2007
Comparison (for pilot beginning on June 30, (effective immediately)
2006)
Conditions Submission has Priority Review Health Canada does not have the
where status capacity and ability to perform an
candidate will Submission qualifies under the Notice electronic review
not be of Compliance with conditions Submission to be assigned to a
considered (NOC/c) policy reviewer on contract
Health Canada does not have the
capacity and ability to perform an
electronic review
Submission to be assigned to a
reviewer on contract or a teleworker


Health Canada:
Implementation Considerations
Issue Co-Submission Hybrid Submission Electronic-only Submission
(Guidance Section 6.1) (Guidance Section 6.2) (Guidance Section 6.3)
Paper content Complete paper-based Modules 1 & 2 in paper No paper
CTD format
Legal record Paper-based submission eCTD submission eCTD submission

Signature Wet ink signature Digitized or scanned copy Electronic signature
required of signed document

Letter of Stating that material in Stating Modules 1 & 2 in Not applicable
Attestation eCTD format exactly eCTD format exactly
matches material in CTD matches material in CTD

Technical pre- Recommended Required To be determined
submission
consultation
Print on Not applicable <500 pages – done by To be determined
demand Health Canada
>500 pages – done by
sponsor on request

FDA Status--Part 15 Hearing
Request for public input to influence development of new
policy/regulation
What do you think about an all-electronic submission
environment?
What do you think about implementing an electronic
platform to promote electronic sharing and exchange of
research and regulatory information?
Public rule being written to mandate electronic
submissions across all Centers of FDA—”years” to reach
final rule
RFI issued for public-private partnership to implement all-
electronic submission environment
http://www.fbo.gov/spg/HHS/FDA/DCASC/e-Platform-RFI/listing.html

FDA Datasets Status -- Study
Data Tabulation Model (SDTM)
FDA Public Meeting February 1, 2005
http://www.fda.gov/oc/datacouncil/presentations.html
Steps being taken by FDA to require submission in electronic format:
Stability datasets – HL7
Animal datasets – tabulation & analysis-ready
Human datasets – tabulation & analysis-ready
Profound change from business as usual
Agency
Sponsors
CROs
Vendors
Additional resources:
http://www.cdisc.org/
http://www.hl7.org/


FDA Status—Electronic
Submission Gateway (ESG)
May 2006 – implemented Electronic Submission Gateway
to enable fully-electronic bidirectional communication
http://www.fda.gov/esg/
If sponsor has electronic signature policy & technology in
place, no paper is required with submissions
Forms (1571, 356h) and documents which require
original wet signature on hardcopy
Acceptable formats
Scanned signatures
Digital signatures
Flattened digital signatures


FDA Status--RPS

Regulated Product Submission (RPS) under
development
Create one model for submission of regulated product
information
Framework for sponsors to send regulatory information
Reviewers able to consistently locate requisite content
Animal and human products—human therapeutics,
medical devices, food additives, veterinary
Worldwide use


FDA Status--RPS

Development under HL7
Randy Levin of FDA CDER one of three Co-Chairs
HL7 being recognized as standards body by ICH
Status
June 2005 RPS Project initiated
Sept. 2006 first test submission to FDA
2010+ implemented as extension to eCTD


RPS--More Information
RCRIM’s TC:
https://www.hl7.org/Special/committees/rcrim/index.cfm
RPS Information Page
https://gforge.nci.nih.gov/plugins/wiki/index.php?Regulated%20
Product%20Submission&id=234&type=g
HL7 tools
https://www.hl7.org/Library/data-
model/V3Tooling/toolsIndex.htm


FDA—SPL Resources

Providing Regulatory Submissions in Electronic
Format – Content of Labeling
http://www.fda.gov/cder/guidance/6719fnl.pdf

SPL Standard for Content of Labeling
Q&As
http://www.fda.gov/cder/guidance/7074fnl.pdf

FDA proposes to perform Indexing of SPL:
http://www.fda.gov/cder/guidance/7662dft.pdf


FDA Data Standards Council

http://www.fda.gov/oc/datacouncil/
Structured Product Labeling
Drug Registration
Drug Listing
Regulated Product Submission
CDISC Data Standards
Stability Data Standards


FDA Resources for CTD

Regulatory Submissions in Electronic Format –
General Considerations
http://www.fda.gov/cder/guidance/4156dft.pdf

eCTD Backbone Files Specification for Module 1
http://www.fda.gov/cder/regulatory/ersr/Module1Spec.pdf

eCTD Backbone Files Specification for Modules 2
through 5
http://www.fda.gov/cder/regulatory/ersr/module2-5spec.pdf



eCTD Backbone Files Specification for
Study Tagging Files (STF)--Module 4 &
Module 5
http://www.fda.gov/cder/regulatory/ersr/FDA%20implementatio
n%20of%20STFv2-6.pdf
Comprehensive Table of Contents
Headings and Hierarchy
http://www.fda.gov/cder/regulatory/ersr/5640C
TOC-v1.2.pdf



Study Data Specifications--Datasets
http://www.fda.gov/cder/regulatory/ersr/Studyd
ata-v1.3.pdf
Portable Document Format
Specifications
http://www.fda.gov/cder/regulatory/ersr/PDF_specification_v11.pdf


Summary
EU & Japan & Canada – eCTD preferred format for
electronic; CTD required format for paper
US – CTD preferred format for paper
Rest of World-- ability to accept & review varies widely
eCTD preferred format for e-Submissions
eCTD remains optional except FDA CDER
Paper submissions required by most countries
Agency cannot legally accept electronic-only
Agency IT infrastructure inadequate to perform electronic
review


eCTD Success! Critical Success Factors:
Faster time to market
Happier stockholders
Greater employee & management
satisfaction
Lower cost of production
Simultaneous global submissions
Healthier patients


Questions & Discussion

Antoinette Azevedo, President & CEO
e-SubmissionsSolutions.com
AAzevedo@e-SubmissionsSolutions.com
http://www.e-SubmissionsSolutions.com/
Telephone (619) 220-7081
Fax (619) 220-0831


Preparing Compliant eCTD Submissions

Recomendados

Recomendados

Mais conteúdo relacionado

Mais procurados

Mais procurados (20)

Semelhante a Preparing Compliant eCTD Submissions

Semelhante a Preparing Compliant eCTD Submissions (20)

Mais de Scott Abel

Mais de Scott Abel (20)

Último

Último (20)

Preparing Compliant eCTD Submissions