Merve B. Email and Phone Number

• Follow up global and local regulatory requirements• Preparing/coordinating registration dossiers in CTD format for MOH(originator products)• Submission and follow up Type I & Type II variations for originator products•Making medical device applications•Attending industry association meetings•Participating in institutional meetings in Ankara when necessary

• Review and assess all regulatory documents and feedback to related departments• Preparing/coordinating registration dossiers in CTD format for MOH (both for originator&generic products) • Submission and follow up Type I & Type II variations both for originator and generic products• Performing the correspondences with Ministry of Health (MOH) and licensor firms• Submission and follow up renewals applications• SmPC (summary of Product Characteristics) & PIL (Patient Information Leaflet) preparation and update • Preparation of responses to health authority questions for products• Preparation of analysis files • Submission Over-the-Counter (OTC) applications • Doing/Managing artwork studies according to current regulations

• Review and assess all regulatory documents and feedback to related departments• Preparation and application of CTD registration application files for generic products• Submission and follow up Type I & Type II variations for generic products• Submission and follow up renewals and co-marketing applications• Preparation of responses to health authority questions for products• Preparation of analysis files• Submission Over-the-Counter (OTC) applications • Submission of export applications files• Translation of Drug Master File (English – Turkish) • Control of artworks of packaging materials according to current regulations

• Preparation of application dossiers in CTD format for generic products • Preparation of analysis files, providing analysis equipment and finished drug products to Healt Authority for analysis• Preparation of Type I & Type II variation application dossiers• Translation of Drug Master File (English – Turkish) • SmPC & PIL preparation and updates • Controling drafts of label-package in according to the current regulation

• Preparing of registration dossier of imported and exported veterinary medicines

• Following quality control analyses process • Following calibration of related equipments• Creating quality documents• Reporting results of analyses

• QC check of raw material , final product and process• Documentation of results• Regular maintenance and house keeping including calibration of laboratory equipments• Following up analysis and cooperation with production department• Analyses of candidate raw materials in order to finalize purchasing process • Cooperation with overseas laboratories• Supporting quality assurance department