Clinres Farmacija d.o.o. is a contract research organization, established in 2000 in Ljubljana, with the goal of providing expert services of high quality in the areas of regulatory affairs, pharmacovigilance and clinical trials.
REGULATORY AFFAIRS Our Regulatory Affairs professionals provide consulting, support and full services for medicinal products for human and veterinary use, medical devices, food supplements, cosmetics and biocides. They also offer preparation of: Modul 2.4 and 2.5; Readability testing; Preparation/compiling/publishing/validation and submission of dossiers in electronic format: eCTD, NeeS; Preparation of Health Based Exposure Limits (HBELs) Reports
PHARMACOVIGILANCE AND VIGILANCE Our Pharmacovigilance professionals offer local and/or global services for marketed medicinal products for human and veterinary use, PVG services for clinical trials, as well as vigilance services
CLINICAL TRIALS Depending on the needs of our client, our team of experts offers a range of services, including a full service from concept to closeout, including, among others, feasibility studies, data management, legal representation services, monitoring and preparation of final reports.