CEE-MED d.o.o. company is capable of providing full service of managing your pharma and medical device business in supplying healthcare system. Our team of professionals has years of experience in managing pharma business and promotion of medicines and medical devices on market of Bosnia and Herzegovina as well in the region of Western Balkans and some of CEE countries. We integrate our knowledge and expertise into our client’s plans in order to develop a business strategy to achieve optimal goals. After reaching consensus with our clients through detailed yearly and long-term plans, we start implementation. During implementation of alligned and approved plans, we take responsibillity for realisation through market research, regulattory affairs, promotional activites, ensuring continuous supply, participating in tender procedures and ensuring timely collection of receivables. With such approach and wide range of services, we provide operational efficiency, efficiacy and cost control to our clients.When you decide to sell your healthcare products on market, one of essential steps is Registration of drugs and medical devices at Medicines and Medical Devices Agency of Bosnia and Herzegovina. We can help you do this efficiently and build a foundation for further business development and enabling smooth further activities. Our regulatory affairs department is responsible for both obtaining and maintaining marketing authorisations. We are striving to provide high quality services, to meet requirements of both our partners and relevant local legislation.
– prepare registration package alligned with Law on Medicines and Medical Devices of Bosnia and Herzegovina and applicable rulebooks
– submitting documentation for registration (CTD or other registration file format) to the Medicines and Medical Devices Agency Bosnia and Herzegovina and follow-up until obtaining
– labelling adjustments and implementation after completing registration
– maintaining valid marketing authorizations through submitting variations and renewal requests
– pharmacovigilance, vigilance of medical devices, obtaining insurance policies for registered medical devices
– market access, drugs market research, medical devices markets research, market assessment and segmentation. Business model planning and development consulting strategy,
obtaining Reimbursement drugs list status.
– Consulting, promoting and positioning drugs and medical devices,