EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and are the only vendor that provides solutions covering the entire regulatory landscape: - Product Registration (XEVMPD & IDMP) - Planning & Tracking (IDMP) - Submission Publishing and Lifecycle Management (eCTD, RPS, CTD, NeeS, IMPD, CTA, eCopy, DMF, ASMF, VNeeS, CADDY, ePRISM, eIndex) - Pharmacovigilance Management and Drug Safety (SUSAR, ICSR, PSUR, DSUR, E2B, MedDRA, SMQ, GVP, CIOMS, MedWatch, R3) Today, EXTEDO enables more than 35 regulatory authorities and over 700 maintained customers across 60 countries to deliver Effortless Compliance™. Our clients range from small CROs to large multi-national pharmaceutical organizations, and we cover industries from biotech to homeopathics, and medical devices to crop sciences. Our mission of Effortless Compliance™ ensures that organizations are able to spend more time doing the things they want to do, rather than the things they have to do. For more information visit www.extedo.com.

Overview

Products and Services Overview

The EXTEDOsuite understands the complexities of the regulated pharmaceutical product journey. From drug design, to market launch and pharmacovigilance surveillance, EXTEDO's suite of software solutions is involved right from the start and includes the following components: - Product Registration (XEVMPD & IDMP) - Planning & Tracking (IDMP) - Submission Publishing and Lifecycle Management (eCTD, RPS, CTD, NeeS, IMPD, CTA, eCopy, DMF, ASMF, VNeeS, CADDY, ePRISM, eIndex) - Pharmacovigilance Management and Drug Safety (SUSAR, ICSR, PSUR, DSUR, E2B, MedDRA, SMQ, GVP, CIOMS, MedWatch, R3) Our software modules can be implemented separately or as a part of a unified Regulatory Information Management Solution. They act as building blocks that enable companies to manage the business critical processes that are essential to maintaining medicinal products. The EXTEDOsuite is designed to work both as a standalone solution or as part of an integrated platform with vendors such as OpenText and can be deployed as Cloud and In-house solutions.