“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.”
“Yes. If an AI tool influences clinical, CMC, or regulatory decisions, you must document how it works, how it was validated, and what controls are in place, regardless of whether the output is "final" or "just a draft." The question that should be asked is not "does it make the decision?" but "does it influence the decision?".”
“Based on the current regulatory frameworks, AI systems used in regulated processes are expected to have documented risk classification, validation evidence, and change control. Responsibility for approving and monitoring the model should be clearly assigned, with defined human oversight.”
“Start with due diligence on the vendor's training data, model evidence, and update practices. Review documentation and contracts. Classify the tool's risk. Make sure you can demonstrate control over updates, performance monitoring, and bias. The depth of qualification depends on the GxP impact of the tool's output.”
“Under the EU Clinical Trials Regulation, the sponsor is the individual or organisation that takes legal responsibility for initiating, managing, and financing the trial.”
“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.”
“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).”
“If your organisation processes health data as a core activity (which most pharma and medtech sponsors do) a DPO is required under GDPR. Even where the formal threshold is debatable, most EU data protection authorities and ethics committees expect a named DPO.”
“Using a cloud-based system with infrastructure or support teams in non-EEA countries creates a cross-border data transfer under GDPR. This requires appropriate transfer mechanisms, typically Standard Contractual Clauses plus a Transfer Impact Assessment. Where ethics committees are not satisfied with the provider's setup, we design hosted alternatives where we control the environment and keep data within the EEA.”
“The Clinical Trials Regulation and the GDPR treat consent differently. Under the CTR, informed consent covers trial participation.”
“Yes to both. We are ourselves ISO 27001 certified, so we've built and maintain the same systems we help clients implement.”
“For standard transactions, we can have a scoped team in place within five to seven working days of engagement. For urgent situations (compressed deal timelines, competing bids), we have mobilised within 48 hours.”
“Yes. On the buy side, we assess targets and flag risks that affect valuation and integration. On the sell side, we help vendors prepare their regulatory and quality documentation for scrutiny, identify and remediate gaps before the process begins, and compile a vendor DD package that supports a smoother transaction. The disciplines are the same; the framing differs.”
“A due diligence site visit is exploratory and time-constrained. We review selected documentation, observe operations, and hold focused discussions with quality and operations personnel to form a preliminary risk picture.”
“This is normal in DD. Sellers control the flow of information, and VDR access often comes in stages.”
“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.”
“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.”
“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.”
“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.”
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