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We bring in specialist market access partners for this work, the same way we bring in CROs for clinical operations or CDMOs for manufacturing.”","path":"/entities/regenold-gmbh-q140571087#company-fact-content-native-digital-agencies-ab479cf0f4f16162-a-ad0e76bb92db40823d71","questionPaths":["/entities/regenold-gmbh-q140571087#company-answer-content-native-digital-agencies-ab479cf0f4f16162-a-ad0e76bb92db40823d71"]},{"id":"content-native-digital-agencies-ab479cf0f4f16162-a-f284b044f7926ab6dbda","label":"What market entry infrastructure can you provide directly?","value":"“We act as MAH on our own licences and operate MIAs in our Irish offices, with a Swissmedic establishment licence in Switzerland. We provide named QPs for batch certification, EU QPPVs, local QPPVs, Stufenplanbeauftragter, and Drug Information Officer / Scientific Service through these.”","path":"/entities/regenold-gmbh-q140571087#company-fact-content-native-digital-agencies-ab479cf0f4f16162-a-f284b044f7926ab6dbda","questionPaths":["/entities/regenold-gmbh-q140571087#company-answer-content-native-digital-agencies-ab479cf0f4f16162-a-f284b044f7926ab6dbda"]},{"id":"content-native-digital-agencies-ab479cf0f4f16162-a-4591d5048634f515fd4b","label":"How does the EU HTA Regulation affect my market access strategy?","value":"“The EU HTA Regulation introduced Joint Clinical Assessments (JCAs) that produce EU-wide clinical evidence evaluations. Since January 2025, JCAs apply to new oncology products and ATMPs.”","path":"/entities/regenold-gmbh-q140571087#company-fact-content-native-digital-agencies-ab479cf0f4f16162-a-4591d5048634f515fd4b","questionPaths":["/entities/regenold-gmbh-q140571087#company-answer-content-native-digital-agencies-ab479cf0f4f16162-a-4591d5048634f515fd4b"]},{"id":"content-native-digital-agencies-ab479cf0f4f16162-a-ec6f98f6761598e4f43e","label":"How do you coordinate between the regulatory submission and market entry?","value":"“We treat them as one programme, not two. 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