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

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Presentation on theme: "Infrastructures For Information Inc. The Collaborative XML Content Company Content Company."— Presentation transcript:

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 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

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

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

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


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