infrastructures for information inc. the collaborative xml content company content company
TRANSCRIPT
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Infrastructures For Infrastructures For Information Inc.Information Inc.
The Collaborative XMLThe Collaborative XML
Content CompanyContent Company
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The Collaborative XML Content The Collaborative XML Content CompanyCompany
Specializing in the Authoring and Lifecycle Management (LCM) of Global Regulatory Documents & Submissions
Helping leading pharmaceutical companies meetHelping leading pharmaceutical companies meet
their FDA & EMEA compliance requirementstheir FDA & EMEA compliance requirements
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Recognized Recognized LeadershipLeadership
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FDA – SPL R4 – FDA – SPL R4 – Registration, Listing, Registration, Listing, LabelingLabeling
Integrated Regulatory SolutionIntegrated Regulatory Solution
EMEA - PIMEMEA - PIM
eCTDeCTD
One platform to author & manage regulatory documents and submissions
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1. Tufts Center for Study of Drug Development2. FDA, 2002; courtesy Ernst & Young
Technology LeadershipTechnology Leadership
1985
1990
1995
2000
2005
2010
Drug Approval Times2
Drug Development Costs1
SGMLISO
standard8879
SGML MERS
project initiated
FDA require
s SPL
(XML)
EMEA accepts
PIM (XML)
XMLW3C
standard
eCTDUS & EU
21cfrp11 issued
FDA negotiates in SPL
XML Clinical
trial protocols
HTML introduc
ed
ICSR
i4i founded
MERS prototypes
x4o and ALiCE
A4L Suite (SPL/PLR/PIM/eCTD)
---------- i4i technology ----------
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The i4i AdvantageThe 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
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XML ContentServices
DocumentManagement
Services
RegulatorySubmission
Services
Patented Word/XML Authoring
User Friendly
Desktop version installs in minutes
Cost EffectiveWord-based
XMLAuthoring
Regulatory Document Lifecycle & Submissions Platform
Authoring Lifecycle Collaborative Environment
IntegrationServices
Solution OverviewSolution Overview
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R4 Ready SolutionsR4 Ready Solutions
Conversion Services
A4L EnterpriseSPL Lifecycle Management
A4L ProfessionalSPL Authoring
www.i4i.com
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A4L A4L for SPL Compliancefor SPL Compliance
Patented Technology
Easy & Familiar MS Word Interface
Powerful SPL Templates
Comprehensive Validation Timely Support of Guidance
& FDA Updates
Desktop to Enterprise Editions
A4L ALiCE 4 Labeling
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SPL Lifecycle ManagementSPL Lifecycle Management
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
A4L Enterprise
www.i4i.com
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Conversion ServicesConversion Services
Fast & Efficient
Same Day Service
100% Validation Guarantee
Electronic Submission Service
now available
CONVERSIONSERVICES
www.i4i.com
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The integration of ALiCE and Register ensures transparent consistency of drug product
information.
ARIS Global:ARIS Global: RegisterRegisterTMTM IntegrationIntegration
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Superior Customer SupportSuperior Customer Support
Monitor your submissions & track progress Prioritize urgent requests Check new announcements
• Recent regulatory guidance• Product hints/tips• New releases
i4i’s Online Customer Care Centre
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Satisfied Customers Satisfied Customers
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The i4i Solution The i4i Solution AdvantageAdvantage
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
Simplifying the preparation and management of regulated XML documents & submissions