Access to the pharmaceutical market in Romania is defined by complex processes and strict requirements. We ensure the coordination of these stages for fast approvals and predictable launches.
Our solid experience in working with authorities, combined with an in-depth understanding of local requirements, enables us to efficiently manage authorization and compliance processes.
•Regulatory affairs consulting
• Preparation, translation, and adaptation of the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC)
• Management of authorization, variation, renewal, and transfer procedures
• Price registration and preparation of dossiers for inclusion in the reimbursed/subsidized medicines list
• Preparation and submission of documentation to competent authorities
• Ensuring pharmacovigilance activities in the distribution of medicinal products
• Fulfillment of VAT, clawback, and other industry-specific tax obligations
• Clawback representation
• Representation in relations with relevant authorities
• The National Agency for Medicines and Medical Devices of Romania
• The Ministry of Health
• The National Health Insurance House
• The Romanian College of Physicians
• The State Office for Inventions and Trademarks
