Our specialism is regulated market access for pharma, medtech, diagnostics and digital health. We also handle market entry in adjacent regulated sectors and general industries — but life sciences is where the depth is.
Three regulated tracks under one thesis: authorized isn't the same as paid.
Reimbursement under AMNOG and the G-BA / IQWiG benefit assessment, commercial model, distribution and local representation.
Pharma → 02 · MedtechMDR / IVDR and CE marking, Notified Body coordination, hospital DRG / NUB vs outpatient G-BA / EBM reimbursement, distribution.
Medtech → 03 · Digital HealthThe BfArM fast-track, the BSI data-security bar, and turning a listing into actual prescriptions.
Digital Health →We take on entry projects outside life sciences too. These run on a lighter, more standard market-entry playbook — useful, but not where our depth lies.
Adjacent regulated
General industries
A short session is the fastest way to know whether Germany is a regulated-access project or a straightforward entry.
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