Dr. Emel Inanc

* Product search and business development for biosimilars * Feasibility preparation for biosimiar products and presentation to investors * Preparation of project proposal to TUBITAK (KAMAG : 1007-SB-2013-01: Biyobenzer İlaçların Yerli Olarak Geliştirilmesi ve Üretilmesi)

* Project coordination and management for a newly established solvent purification facility * Feasibility preparation, P & L Analysis * Environmental Assesment Report (ÇED) preparation * Preparation of Quality system for ISO 9001, 14001 and OHSAS 18001 * Business development for new product search including chemicals and food additivies * Preparation of GMP Audit Docs for oditing an abroad plant of exported drug

* Scale-up of the production of new licenced and contract manufacturing products * Directed projects to develop over 40 generic drugs in all forms including veterinary and cosmetics * Developed products, directed the projects and prepared technical dossier for marketing the generic drugs in EU member states. Roxithromycine, Cefotaxime & Ceftriaxone have been marketed in EU. * GMP, GLP and ISO 9001 experiences.

* Dossier examination of the in-license products: about 15 molecules including biopharmaceticals. * New product search and proposal, in-license products: 3 important oncology medicines * Costumer search and out-license activities * Coordination of R&D and registration department * Consultant in the department for R&D, manufacturing and registration issues for both Turkey and abroad including EU registrations

* R & D Coordination * Conducting Bioequivalence and Biowaiver Studies, completed 55 projects in 3 years * New products medical and data exclusivity examination * Preparation of expert reports and pharmaceutical development section of files in NTA format * Preparation of Common Technical Document (CTD) for Turkish MoH and EU member states : Module 2, Module 3: only 3.2.P.2 Pharmaceutical Development, Module 4, Module 5 * Dossier examination of the in-license products

* Investigation and follow up of EU legislation * Preparation of EU Health Guidelines in Turkish, i.e. GMP, Variations Type I-II, * Registrations of Biotechnology Products, CTD. * Organization of scientific meetings * Preparation of different projects related with pharmaceutical industry.

* Prepared of CTD – DMF for FDA application of a molecule * Consultant for DMF preparation * Established quality assurance system for FDA audit

Biochemical engineering (An investigation of Oxygen Transfer Limitations on the metabolism and Growth of Escherichia coli)

Analyses of the Liquefaction Products of Mengen Lignite Based on Fractionation Techniques