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Infrastructures For Infrastructures For Information Inc.Information Inc.
The Collaborative XMLThe Collaborative XML
Content CompanyContent Company
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
Recognized Recognized LeadershipLeadership
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
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 ----------
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
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
R4 Ready SolutionsR4 Ready Solutions
Conversion Services
A4L EnterpriseSPL Lifecycle Management
A4L ProfessionalSPL Authoring
www.i4i.com
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
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
Conversion ServicesConversion Services
Fast & Efficient
Same Day Service
100% Validation Guarantee
Electronic Submission Service
now available
CONVERSIONSERVICES
www.i4i.com
The integration of ALiCE and Register ensures transparent consistency of drug product
information.
ARIS Global:ARIS Global: RegisterRegisterTMTM IntegrationIntegration
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
Satisfied Customers Satisfied Customers
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