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We are offering the following services: • Obtaining the marketing authorization releasing by the National Medicinal Agency through mutual recognition procedure (MRP), decentralized procedure (DCP) and community procedure directly to European Medicinal Agency (EMEA) • Coordination of post-authorization procedures: day to day correspondence between partners, variations, line extensions, changes of marketing authorization holder, pharmacovigilance • Verification of active and inactive ingredients for food supplements cosmetics and obtaining of valid notification for placing them on the market • Verification of active and inactive ingredients for baby food and obtaining of valid notification for placing them on the market • Obtaining the marketing authorization for medical devices • Obtaining the valid notification for placing the herbal medicinal product on the market (tee, herbal food supplements) • Consultancies on legislation matters ( medicinal products, food supplements, cosmetics, medical devices) • Consultancies on advertising materials • adverse drug reaction collecting • adverse event for medical device • scientifically literature scanning • abstracts translating from scientifically literature (English-romanian/Romanian-english) • PSURs preparation • Electronic transmission of ICSRs in EU • PSURs syncronisation scheme • Summary of product characteristics, labelling and Patient Information eleboration and translation (English-romanian/Romanian-english) • Pharmacovigilance system conception – Standard Operation Procedure elaboration
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Româna