regenold GmbH
regenold GmbH: “regenold GmbH is an end-to-end integrated development partner for pharmaceuticals, medical devices, and drug-device combination products. Since 1994, regenold has guided more than 2,000 innovators through over 10,000 successful product submissions across 90+ countries.”
Do you handle HTA dossiers and pricing negotiations directly?
“Health economics, value dossier authoring, and payer negotiations are specialist disciplines that require dedicated expertise. We bring in specialist market access partners for this work, the same way we bring in CROs for clinical operations or CDMOs for manufacturing.”
View in the company profileWhat market entry infrastructure can you provide directly?
“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.”
View in the company profileHow does the EU HTA Regulation affect my market access strategy?
“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.”
View in the company profileHow do you coordinate between the regulatory submission and market entry?
“We treat them as one programme, not two. The regulatory team that manages the submission also ensures market entry infrastructure is in place before the MA is granted.”
View in the company profile