Clinres farmacija
Clinres Farmacija is a leading provider of clinical research, regulatory affairs, and pharmacovigilance services in Central and Eastern Europe. Established in 2000, the company offers comprehensive services throughout the entire lifecycle of healthcare products, including clinical trials, regulatory submissions, pharmacovigilance, and medical device services. With a strong regional presence and a team of experienced professionals, Clinres Farmacija aims to deliver high-quality, reliable, and innovative solutions to its clients, supporting the development and registration of medicines and medical devices.
Industries
Nr. of Employees
medium (51-250)
Clinres farmacija
Zagreb, Grad Zagreb, Croatia, Europe
Services
End-to-end clinical trial support including feasibility, site selection, monitoring, CRF/eCRF design, medical writing, and project management for multi-country studies.
Regulatory strategy, dossier preparation and submissions (national, MRP/DCP/CP), eCTD compilation, post-approval support and regulatory intelligence.
Global and local PV services including establishment and maintenance of PV systems, provision of QPPV/local contacts and literature screening.
Gap analyses to MDR/IVDR, technical documentation preparation, UDI implementation, clinical performance evaluation and post-market surveillance support.
CRF/eCRF design, data management planning, statistical plan development, programming and reporting for clinical studies.
GMP/GDP-compliant storage, temperature-controlled warehousing, import/export licensing, study medication distribution, monitoring and destruction procedures.
End-to-end clinical trial support including feasibility, site selection, monitoring, CRF/eCRF design, medical writing, and project management for multi-country studies.
Regulatory strategy, dossier preparation and submissions (national, MRP/DCP/CP), eCTD compilation, post-approval support and regulatory intelligence.
Global and local PV services including establishment and maintenance of PV systems, provision of QPPV/local contacts and literature screening.
Gap analyses to MDR/IVDR, technical documentation preparation, UDI implementation, clinical performance evaluation and post-market surveillance support.
CRF/eCRF design, data management planning, statistical plan development, programming and reporting for clinical studies.
GMP/GDP-compliant storage, temperature-controlled warehousing, import/export licensing, study medication distribution, monitoring and destruction procedures.
Expertise Areas
- Clinical trial management
- Clinical monitoring and site management
- Clinical data management and biostatistics
- Regulatory affairs and submissions (human and veterinary)
Key Technologies
- Electronic data capture (eCRF)
- eCTD regulatory submission format
- Unique Device Identification (UDI) systems
- Temperature-controlled cold chain monitoring
News & Updates
Survey and discussion on patient involvement and perceptions in clinical trials.
Guidelines and insights on the safe use of medicinal products during pregnancy.
Historical overview of major drug recalls and pharmacovigilance lessons, including thalidomide and Vioxx.
Development and approval of gene therapy, including ethical considerations and approved drugs.
Overview of orphan drugs, regulatory pathways, and market approval process.
Potential applications of blockchain technology in healthcare, including EMRs and supply chain.
Survey and discussion on patient involvement and perceptions in clinical trials.
Guidelines and insights on the safe use of medicinal products during pregnancy.
Historical overview of major drug recalls and pharmacovigilance lessons, including thalidomide and Vioxx.
Development and approval of gene therapy, including ethical considerations and approved drugs.
Overview of orphan drugs, regulatory pathways, and market approval process.
Potential applications of blockchain technology in healthcare, including EMRs and supply chain.