EXTEDO
Nikola Kocev is a seasoned professional in regulatory affairs and product management with extensive experience in the pharmaceutical industry. Currently serving as a Product Manager at EXTEDO since February 2022, Nikola previously held the position of Regulatory Operations Manager at ALKALOID AD Skopje, where responsibilities included the establishment of the Regulatory Operations unit and implementation of various management systems. Prior roles encompassed regulatory oversight and quality representation at GSK, as well as regulatory and quality control responsibilities at the Pharmaceutical Industry Inter-Evrogeneks. Nikola holds a Specialist degree in Industrial Pharmacy and a Master of Pharmacy from Ss. Cyril and Methodius University of Skopje.
This person is not in any offices
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.