Şeyma Henzgen

•Writing and editing the CMC Sections of regulatory Documents for EU and international Countries •Preparation of Applications for regulatory Variations •Preparation of regulatory Documents including CMC responses to regulatory Authorities •Participation in cross-functional Teams (Product Development Manufacturing, Supply Chain and all Quality Functions) •Tracking and Maintenance of all regulatory deficient Correspondences •Filling of new Product Submissions to domestic and international Regulators

• Developing Formulations and Technologies for parenteral and oral solid Drug Products • Participation in Research Projects • Scale-up and Technology Transfer Support to commercial Manufactur-ing Facilities • Optimization of Formulation and Process for commercial Drug Prod-ucts • Preparation of technical regulatory Documents (Module 3) and Appli-cations for regulatory Variations

Responsible for developing original and generic formulations Conducted drug production processes (pilot scale and biobatch) Prepared R&D Innovation Project

IP Consultant for Drug patents for domestic and international clients Conducted equivalent patent search for pharmaceuticals Prepared FTO reports, infringement reports and technical reports Prepared draft patent specification

Study emphases: Non-Steroidal Anti-inflammatory Drug Nanosuspension for Ophthalmic Application Final Degree: 3,36/4

Study emphases: Nanocrystals and Methods for Preparation of Nanocrystals Graduation Degree: 3,50/4 (High Honors Degree)