From assessment to patients, without building Europe yourself.
US biotechs are rightly focused on clinical development and the US launch. Europe needs different expertise, at a different time, and the infrastructure required is fragmented, expensive, and arrives too early in the asset’s life. Mirava Bio covers that ground for you. We don’t just advise. We operate on your behalf, cross-functionally, as your fully outsourced European team. One lead engagement and accountable interface, with full visibility, while you retain ownership, strategic control and agreed decision rights, and any MAH statutory responsibilities are clearly allocated.
Each step ends with a decision: stop, go or defer. Time-critical work can run alongside assessment and planning.
Three of them can still be shaped today, and each moves the value of your European opportunity.
Client names under NDA. All delivered in the last six months.
Eight functions, one team, one contract. We recruit the right subject-matter experts and agencies, always with your approval, from internal Mirava experts and a vetted specialist network at negotiated rates, then run everything cross-functionally on your behalf: managed timelines, holistic strategic control. Your team stays focused on the US launch, with no disruption to headquarters.
ODD application dossier, EMA scientific advice, PRIME, MAA compilation & submission, CHMP responses, national authorisations, and holding your MAH & ODD as EU sponsor.
JSC / JCA, value dossier, pricing strategy, international-reference-pricing management, national pricing and reimbursement negotiations, and outcomes-based agreements where relevant.
MAH, QPPV, WDA / GDP / GMP vendor selection and oversight; QMS frameworks; mock inspections.
Module 3 EU bridge, QP release, ATMP cold chain, 3PL qualification, GMO permits, serialisation.
KOL Access Champions, COE certification, scientific platform, RWE protocols, guideline strategy.
FR AP1/AP2, IT 648/96, DE §2 SGB V, CH 71a-d, FDA spillover (UAE, KSA, GR, ES), chargeable.
Cross-border concierge service, patient organisation engagement, eligibility & screening campaigns.
Operating-model selection, KAM & medical SME teams, hospital procurement, launch sequencing.
Yes. Through Mirava Bio BV, our Dutch entity in The Hague, we can hold your European Marketing Authorisation and, where appropriate, act as your EU Orphan Drug Designation sponsor, a role that requires an EU-established sponsor. You access Europe without setting up a legal entity or affiliate, while retaining ownership, pricing authority and strategic control.
It means a fully outsourced European team that plans and executes your market entry on your behalf, regulatory, MAH & ODD sponsorship, quality, supply chain, market access, medical affairs and commercial execution, under one contract, for innovative biotech and pharma with no commercial footprint in Europe.
Through a partner-based commercialisation model. Mirava Bio integrates as an outsourced European team covering regulatory affairs, market access and HTA, quality and compliance, CMC and supply chain, medical affairs, early access programs, patient advocacy and commercial readiness, under one contract, while the biotech retains ownership, pricing authority and strategic control.
At late Phase 2. European regulatory (EMA), HTA / Joint Clinical Assessment and early-access timelines run in parallel with US development. Starting at the Phase 2 readout protects option value and avoids costly rework, without committing to structural investment before the data warrants it.
A sequence of ten decision gates (G1, G10): readiness and scenario planning, orphan drug designation and PRIME strategy, Joint Scientific Consultation and PIP alignment, CMC bridging and QP designation, pricing architecture, early access programs, MAA submission with parallel Joint Clinical Assessment, CHMP opinion and EU marketing authorisation, national HTA dossiers, and signed pricing and reimbursement agreements.
Yes. France’s Accès Précoce, Italy’s Law 648/96, Germany’s §2 SGB V and Switzerland’s Art. 71a-d KVV allow chargeable early access before marketing authorisation, generating first EU revenue while real-world evidence feeds later HTA submissions.
Only around 260 orphan drugs are approved in the EU versus roughly 880 in the US, about 30%. Fragmented markets, high upfront affiliate costs, complex regulatory pathways and country-by-country pricing negotiations deter emerging biotechs, even though Europe represents over 40% of global rare disease drug sales.
Yes. The engagement is decision-gated and reversible: stop, go or defer at every milestone. Vendor contracts, operational systems and institutional knowledge transfer to the biotech’s team whenever it is ready to internalise. Pricing, strategy, IP and ownership always stay with the company.
Practical guidance on rare disease, ATMP and cell & gene therapy market entry in Europe.
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.
Read more →