RAMACO has excellent understanding and experience in Regulatory laws, processes, mindset, document requirements, and drug labeling, pricing, and reimbursement requirements in Western Balkan countries.
Our service include consultancy on the national regulatory environment related to wide range of products: medicines, medical devices and dietary supplements.
Right from dossier screening, planning, tracking, completing, adapting to local national requirements and submitting final documents to HAs to delivery confirmation/acknowledgement, RAMACO streamlines the entire Health Authority (HA) submission management process to ensure error-free, timely and quality regulatory submissions throughout the Lifecycle.
We offer our Customers a wide range of solutions for successful market access, assuring the highest compliance to ethical principles.