Services
Unlicensed medicines
- Import and distribution of non-registered products (medicines registered in the country of origin, but not registered in the country of Importation)
- Our wholesale company specializes in the delivery of non-registered products to end-users, including niche, orphan drugs, and products experiencing shortages in specific markets.
- We are active in the following therapeutic areas: oncology, hematology, infectious diseases, cardiology, anaesthesia, neurology, gastroenterology, urology, and psychiatry.
- Our primary clients include clinics, clinical hospital centres, institutes, general hospitals, and pharmacies, both state and privately-owned.
Consulting services - registration of medicines and medical devices
- We provide expert market analysis services for your portfolio and market opportunities.
- Our regulatory services are comprehensive, covering the entire process of product registration/maintenance of marketing authorization and all necessary interactions with Competent Authorities prior to product launch.
- We offer support prior to the issuance of marketing authorization, including the preparation and submission of applications, supplementation of documentation upon request, procedural advice, and communication with Competent Authorities.
- Our team is equipped to handle the preparation and review of translations of product information such as Summary of Product Characteristics, Patient Information Leaflet, and labelling, ensuring compliance with national regulations.
- We offer pricing support, including the preparation and submission of applications for maximum wholesale price approval and inclusion into the Reimbursement List of the Republic Fund of Health Insurance.
Market access programs for orphan drugs
- We establish market access programs for innovators, our aim is to efficiently capture and fulfil requests for access to orphan drugs in non-launched markets, handling market access (securing reimbursement and obtaining the right price), and market placement of medicine as unlicensed.
- We offer a comprehensive commercial infrastructure, managing all operational aspects including distribution, registration, medical affairs and pharmacovigilance, logistics and territorial coverage, as well as sales and marketing.
- Our experienced team of Medical Science Liaisons and Key Account Managers guarantee disease awareness, consistent messaging to healthcare providers, and the implementation of best practices for fast-track access to life-changing treatments and the fulfilment of unmet medical needs.
