Zwiers Regulatory Consultancy BV
Dirkje Oortwijn has extensive experience in regulatory affairs and pharmacovigilance, currently serving as a Regulatory/Pharmacovigilance Consultant at Zwiers Regulatory Consultancy BV since January 2022. Prior to this role, Dirkje worked as a Pharmacovigilance Officer at Basic Pharma Interdos BV from February 2017 to January 2022 and held the position of Regulatory Affairs Officer at Linde Gas Therapeutics from August 1999 to January 2017. At Linde, Dirkje was responsible for submitting registration dossiers, maintaining registrations, and managing both pharmacovigilance and materiovigilance cases. Earlier experience includes a role as a Quality Engineer at Robert Bosch Packaging Technology B.V. and a Quality Technician at Oce. Dirkje holds a Bachelor's degree in Analytical Chemistry from Hogeschool Drenthe, obtained between 1991 and 1996.
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Zwiers Regulatory Consultancy BV
Zwiers Regulatory Consultancy provides full regulatory support, throughout the entire drug lifecycle. From initial clinical trial application to post-marketing compliance, from A to Z. Our services include: - Regulatory strategic advice - Writing, reviewing and compiling of regulatory/PV documents and eCTDs - Regulatory intelligence and training For more information: Alex Zwiers, CEO Tel: +31 (0)6 10489150 info@az-regulatory.com www.az-regulatory.com