1. Infrastructures For Information Inc. The Collaborative XML Content Company Content Company

2. The Collaborative XML Content Company Specializing in the Authoring and Lifecycle Management (LCM) of Global Regulatory Documents & Submissions Helping leading pharmaceutical companies meet their FDA & EMEA compliance requirements their FDA & EMEA compliance requirements

3. Recognized Leadership

4. FDA – SPL R4 – Registration, Listing, Labeling Integrated Regulatory Solution EMEA - PIM eCTD One platform to author & manage regulatory documents and submissions

5. 1.Tufts Center for Study of Drug Development 2.FDA, 2002; courtesy Ernst & Young Technology Leadership 19851990199520002005 2010 Drug Approval Times 2 Drug Development Costs 1 SGML ISO standard 8879 SGML MERS project initiated FDA requires SPL (XML) EMEA accepts PIM (XML) XML W3C standard eCTD US & EU 21cfrp11 issued FDA negotiates in SPL XML Clinical trial protocols HTML introduced ICSR i4i founded MERS prototypesx4o and ALiCEA4L Suite (SPL/PLR/PIM/eCTD) ---------- i4i technology ----------

6. 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

7. XML Content Services Document Management Services Regulatory Submission Services Patented Word/XML Authoring User Friendly Desktop version installs in minutes Cost Effective Word-based XML Authoring Regulatory Document Lifecycle & Submissions Platform Authoring Lifecycle Collaborative Environment Integration Services Solution Overview

8. R4 Ready Solutions Conversion Services A4L Enterprise SPL Lifecycle Management A4L Professional SPL Authoring www.i4i.com

9. A4L for 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

10. SPL 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

11. Conversion Services Fast & Efficient Same Day Service 100% Validation Guarantee Electronic Submission Service now available CONVERSION SERVICES www.i4i.com

12. The integration of ALiCE and Register ensures transparent consistency of drug product information. ARIS Global: Register TM Integration

13. Superior Customer Support Monitor your submissions & track progress Prioritize urgent requests Check new announcements Recent regulatory guidance Product hints/tips New releases i4is Online Customer Care Centre

14. Satisfied Customers Satisfied Customers

15. The i4i Solution Advantage 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