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.”
What does it mean when you “act as sponsor” for an EU clinical trial?
“Under the EU Clinical Trials Regulation, the sponsor is the individual or organisation that takes legal responsibility for initiating, managing, and financing the trial.”
View in the company profileWhat is the difference between an EU sponsor and an EU legal representative?
“If you're a non-EU company, the CTR requires you to either have a sponsor established in the EU or designate an EU legal representative. As legal representative, we act as your contact point for EU authorities and ensure that the sponsor's obligations under the CTR can be enforced in the EU, but the sponsor retains overall responsibility.”
View in the company profileHow has ICH E6(R3) changed how you design trials?
“ICH E6(R3) was finalised in January 2025 and became effective in the EU in July 2025. The biggest practical changes are the emphasis on quality by design (identifying “critical to quality” factors upfront), proportionate monitoring (risk-based rather than 100% source data verification), and formal recognition of decentralised trial elements (remote consent, home delivery of IMP, wearable data capture).”
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