Transcript i4i DIA overview

Infrastructures For Information Inc.
The Collaborative XML
Content Company
The Collaborative XML Content Company
Helping leading pharmaceutical companies meet
their FDA & EMEA compliance requirements
Specializing in the Authoring and
Lifecycle Management (LCM) of
Global Regulatory Documents &
Submissions
Recognized Leadership
Integrated Regulatory Solution
One platform to author & manage
regulatory documents and submissions
FDA – SPL R4 – Registration, Listing, Labeling
EMEA - PIM
eCTD
Technology Leadership
Drug Approval Times2
Drug Development
Costs1
---------- i4i technology ---------i4i founded MERS prototypes
1985
1990
SGML
ISO
standard
8879
HTML
introduced
1995
SGML
MERS
project
initiated
21cfrp11
issued
x4o and ALiCE
2000
XML
W3C
standard
ICSR
A4L Suite (SPL/PLR/PIM/eCTD)
eCTD
FDA
US & EU requires
SPL
(XML)
EMEA
accepts
PIM
(XML)
1.
2.
Tufts Center for Study of Drug Development
FDA, 2002; courtesy Ernst & Young
2010
2005
FDA
negotiates
in SPL
XML
Clinical
trial
protocols
The i4i Advantage
Thought, Technology & Industry Leadership
Leading-edge XML Compliance Solutions


Industry Standard User Interfaces/Ease of Use
Solutions to Support Authoring & LCM of Global
Regulatory Submissions (SPL/PLR, SPL R4 for
Establishment Registration, Listing etc. PIM, eCTD)
Satisfied Customers
Solution Overview
Regulatory Document Lifecycle & Submissions Platform
Patented Word/XML Authoring
User Friendly
Desktop version installs in minutes
Word-based
XML
Authoring
Cost Effective
Authoring Lifecycle Collaborative Environment
XML Content
Services
Document
Management
Services
Regulatory
Submission
Services
Integration
Services
R4 Ready Solutions
A4L Professional
SPL Authoring
A4L Enterprise
SPL Lifecycle
Management
Conversion
Services
www.i4i.com
A4L for SPL Compliance
A4L
ALiCE 4 Labeling

Patented Technology

Easy & Familiar MS Word Interface

Powerful SPL Templates

Comprehensive Validation

Timely Support of Guidance
& FDA Updates

Desktop to Enterprise Editions
SPL Lifecycle Management
A4L
Enterprise
 Authoring & Life Cycle Management of
compliant global labeling submissions
including SPL, PIM & eCTDs.
 Single, Authoritative view of Label Content
 Seamless integration with A4L Professional
 Content grouped by “Aboutness”
 Content Efficiency & Reuse
 Translation management
 Workflow, Metadata and Access
 Easy to use Interface
www.i4i.com
Conversion Services
CONVERSION
SERVICES

Fast & Efficient

Same Day Service

100% Validation Guarantee

Electronic Submission Service
now available
www.i4i.com
ARIS Global: Register Integration
TM
The integration of ALiCE and Register ensures
transparent consistency of drug product information.
Superior Customer Support
i4i’s Online Customer Care Centre
 Monitor your submissions
& track progress
 Prioritize urgent requests
 Check new announcements
• Recent regulatory guidance
• Product hints/tips
• New releases
Satisfied Customers
The i4i Solution Advantage
Simplifying the preparation and management
of regulated XML documents & submissions
Integrated platform for SPL/PLR, SPL Release 4
(Establishment Registration, Listing etc.) EMEA/PIM,
SOPs, eCTD, 21CFR11 Document Management
Fast Implementation & Easy to use
Superior Customer Support Services