One partner across the entire European pathway: strategic go-to-market advisory paired with a licence-ready commercial platform — phased, de-risked, and always in your control.
Through Mirava Bio BV, our Dutch entity in The Hague, Mirava Bio acts as the European Marketing Authorisation Holder (MAH) and, where appropriate, the EU Orphan Drug Designation holder for biotechs with no commercial footprint in Europe. You access Europe without establishing a legal entity, building an affiliate, or investing in a fixed-cost organisation — while retaining full strategic control, pricing authority, and long-term asset value. We provide the regulatory, quality and supply chain infrastructure; you keep ownership.
End-to-end regulatory sponsorship, not just a name on the file. We take the dossier from the early Orphan Drug Designation application and EMA scientific advice, through PRIME eligibility and the MAA compilation and submission, to holding the resulting Marketing Authorisation and ODD as your EU-established sponsor. Our internal experts orchestrate the work with a vetted specialist network — always with your approval — so you retain full strategic control while we own accountability for delivery.
We design de-risked entry strategies that align regulatory, market access, medical and commercial priorities into one roadmap — fully integrated with your TPP, resource allocation, market prioritisation and global vision.
We ensure smart, value-driven use of capital, prioritizing high-impact activities and sequencing investments for maximum return.
Clear, time-bound roadmaps linking science, market readiness and access — each phase measured and aligned with investor and board expectations.
When eligible for Early Access Programs (EAP), we integrate them into your strategy to generate early revenue while preparing for launch.
We align regulatory, access, medical, supply-chain and commercial workstreams so your teams move together — accelerating time-to-market and avoiding costly misalignment.
We leverage regional clusters to define the smartest entry sequence based on regulation, pricing and logistics — enabling faster approvals and coordinated growth.
We build strategies with empathy and precision for small patient populations and complex pathways.
We integrate as your temporary commercial affiliate — a licence-ready platform covering quality, safety, distribution, patient services and field deployment — so you can launch across EMEE without building affiliates.
Our integrated platform and seasoned team streamline entry into EMEE markets, reducing lead times and maximizing biotech valuation.
Partners retain authority over pricing, commercialization strategy and critical decisions while leveraging Mirava Bio’s infrastructure.
Our advanced digital platform ensures seamless management of the product lifecycle, enhancing efficiency and decision-making.
With deep experience of rare disease therapies, we offer tailored strategies to overcome unique market challenges.
Flexible services that grow with your needs — the same partner, from day one to the lifecycle management of your products.
A fully flexible model that minimizes risk and upfront costs while optimizing efficiency — letting you retain full control and ownership.
Mirava Bio is building a fully licensed commercial organisation (WDA, GDP) ready to enable compliant ATMP and rare disease drug commercialisation. Applications are underway, and we adapt our licensing portfolio to match product profiles, expanding as needed to ensure seamless market entry.