Practical guidance on rare disease, ATMP and cell & gene therapy market entry in Europe — from regulatory strategy and early access to HTA and pricing.
Our Dutch entity in The Hague now serves as European Marketing Authorisation Holder (MAH) and EU Orphan Drug Designation holder for biotechs with no European footprint.
Read more →A decision-gated map of the European pathway — from late-Phase 2 readiness to signed pricing and reimbursement agreements.
Read more →How France, Italy, Germany and Switzerland let rare disease therapies reach patients — and earn revenue — before approval.
Read more →The EU HTA Regulation timeline and what the parallel Joint Clinical Assessment means for ATMP and orphan developers.
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