Due Diligence Support

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. Team composition depends on the scope: a single-product dossier review may need two to three specialists, while a multi-country portfolio assessment can require a cross-functional team of eight or more, drawing on regenold's own teams and regulanet® partners for local market expertise.

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. A formal GMP audit follows a defined methodology, covers a full scope against regulatory or internal standards, and produces findings with formal classification. During DD, site visits are typically the most we can do within the timeline. If findings from the visit indicate a need for a formal audit, we recommend it as a post-close workstream.

Through regulanet®, our global network of independent regulatory service providers. For each target market, we engage local experts who assess region-specific regulatory requirements, MA status, post-approval obligations, and market access considerations. regenold coordinates the overall assessment, consolidates findings, and delivers a single integrated report. The client has one contract and one point of contact.

Yes. For pipeline assets, we evaluate the clinical development plan against current regulatory expectations, assess CMC readiness for the next development milestone, and review the regulatory strategy for plausibility. We provide a probability-of-approval assessment based on the data available, the regulatory pathway chosen, and comparability with precedent approvals. This is not a statistical prediction; it is a structured expert assessment that highlights the specific risks and gaps.

This is normal in DD. Sellers control the flow of information, and VDR access often comes in stages. We structure our work to provide useful outputs at each stage: an initial screening based on public data, a deeper assessment once VDR access is granted, and refinements as additional documents or Q&A responses become available. We are explicit about what we have reviewed, what we have not, and what the residual uncertainty means for the deal.

Our DD scope typically ends with the risk report and recommendations. However, many of the workstreams that arise post-completion of the transaction (MA transfers, PV system setup, QMS integration, regulatory submissions for the acquired portfolio) are core regenold services. Continuity from DD into integration is one of the advantages of working with a regulatory services firm rather than a generalist consulting practice: the team that identified the risks is available to resolve them.

DD is scoped and quoted on a per-project basis, reflecting the number of products, markets, and disciplines involved. We do not bill hourly with an open-ended estimate. At the outset of every engagement, we agree on scope, deliverables, timeline, and cost. If scope changes during the transaction (as it often does), we discuss and agree on adjustments before incurring additional cost.

Medical device transactions require assessment of the technical documentation (the device equivalent of the pharmaceutical dossier), the Notified Body relationship and certificate status, the quality management system against ISO 13485, and post-market surveillance compliance under MDR/IVDR. Key risk areas include: incomplete or outdated technical documentation that won't survive NB re-certification, certificates approaching expiry without a clear renewal pathway, IVDR transition gaps for legacy IVDs, and single-source supplier dependencies for critical components. We assess all of these as part of our device DD workstream.