Marti Farm Ltd, company based in Zagreb, Croatia, is dedicated to providing a comprehensive package of regulatory affairs services to domestic and foreign pharmaceutical and biotechnology companies.
We are a trusted partner to companies that value smart resource management, helping them to be focused on their business goals while acquiring value-added high quality services.
Full service including system management, 24/7 QPPV or DQPPV availability, PV inspection contact in Croatia, electronic reporting of adverse reactions ( E2B ), monitoring of adverse events, continuous monitoring of the safety profile of medicines
2. Literature screeening
We provide this service as part of our Pharmacovigilance system and for medical writing services, conducting global and local literature screening in any area of interest. We can also conduct a search of a specific area, and write up a report with all the necessary information.
3. PASS trials
4. DHPC - Direct Healthcare Professional Communication
5. Medical writing
• Periodic Safety Update Report, PSUR
• Clinical overview, addendum to clinical overview
• Risk management plan - RMP
• Summary of Product Characteristics, SmPC
• Patient Information Leaflet, PIL
6. Medicinal product registration
We provide services of registration, renewal of registration and approval of amendments to the marketing of drugs, medical devices, foods for special medical needs and dietary supplements. We can also provide services of Local representative company and LQPPV required by Croatian laws and regulations, wholesalers contact and management as well as reimbursement process.
7. Readability user PIL testing
8. Regulatory services
9. Audit and Inspection
10. Quality Risk management
12. Market access