EXTEDO
Kevin Horan is a highly experienced professional in the fields of information and communications technology, business services, and regulatory affairs, currently serving as Senior Agency Practice Manager at EXTEDO since April 2021. Horan has a diverse background, having held significant roles such as Senior Manager in CIO Advisory at BearingPoint and Director of ICT and Business Services at the Health Products Regulatory Authority (HPRA). Horan's extensive experience includes strategic project management, business analysis, and process optimization, with a strong focus on health product regulation and e-business. Horan's educational accomplishments include multiple postgraduate diplomas in Digital Transformation and Regulatory Affairs, contributing to a robust foundation in pharmaceutical business operations.
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EXTEDO
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.