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 provide solutions covering the entire regulatory landscape:
Document Management
Planning & Tracking
Product Registration (XEVMPD & IDMP)
Submission 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 around 35 regulatory authorities and 1000 maintained customers across 65 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.
Industry
Software Development, Pharmaceutical industry - machinery and equipment, Chemicals & Pharmaceuticals - Machines & Equipment, Mechanical Engineering & Industry - Equipment, Chemical and pharmaceutical industry - machinery and equipment, Internet services, Information technology (IT) and Internet, IT, Internet, R&D, Software consultants, Information technology (IT) systems consultants
HQ Location
Einsteinstrasse 30
Ottobrunn, Bavaria 85521, DE
Keywords
Regulatory Information ManagementSubmission Publishing & Lifecycle Management (eCTDNeeSetc.)Product Registration Planning & Tracking (XEVMPD & IDMP)Pharmacovigilance Management (SUSARICSRPSURE2BMedDRA