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