http___martifarm.hr_hr_usluge_medical-writing.html_1.xml
1.1 2.1 3.1 4.1 5.1 6.1 7.1 9.1 10.1
Medical writingWe offer services of medical writing of documentation in the field of pharmacovigilance and regulatory issues. Services that we provide: - Pharmacovigilance documents such as Periodic Safety Update Report Risk (PSUR's/DSURS's) Management Plans (RMP's), Addendum to Clinical Overview's - Summary of Product Characteristics, SmPC and Patient Information Leaflet, PIL - Study Protocols - Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Contract Research Organisation (CRO) - Clinical and non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU Regulatory Authorities We guarantee our partners and clients that all services hired will be carried out successfully, on time and will bring added value to their organizations. With our support, you save the time and associated expenses  to bridge the gap between the regulated and the regulators and ultimately provide faster and safer service to patients.
1.1 2.1 3.1 4.1 5.1 6.1 7.1 8.1 9.1 10.1 11.1 12.1
Medical writingNudimo usluge izrade dokumenata iz područja farmakovigilancije i regulatornih pitanja. Dokumenti koje izrađujemo su: - Farmakovigilancijski dokumenti kao što je Periodičko izvješće o neškodljivosti lijeka (PSUR/DSUR), Plan upravljanja rizicima (RMP), Addendum to Clinical Overview - Sažetak karakteristika proizvoda, SmPC, Uputa o lijeku, PIL - Protokoli studija - Standardne operativne procedure (SOP) koje pokrivaju sve dijelove razvoja lijeka uključujući dizajn, provođenje i prijavu kliničkih ispitivanja te pružanje usluga - Periodičko izvješće o neškodljivosti lijeka, PSUR - Sažetak karakteristika proizvoda, SmPC - Uputa o lijeku, PIL - Pisana komunikacija s liječnicima, DHPC Jamčimo našim partnerima da ćemo sve ugovorene usluge izvršiti uspješno i na vrijeme i na taj način pružiti dodanu vrijednost njihovim kompanijama. Uz našu potporu štedite vrijeme i prateće troškove kako biste premostili jaz između onih koje se regulira i onih koji reguliraju kako biste na kraju pružili bržu i sigurniju uslugu pacijentima.